Renal Cell Carcinoma (Kidney Cancer)RECLNDNCT07321197
Radical Nephrectomy With vs Without Template Lymph Node Dissection in High-Risk Renal Cell Carcinoma (T-LND RCC)
A study testing Template Lymph Node Dissection and Selective Lymph Node Resection in people with Renal Cell Carcinoma (Kidney Cancer), run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if a more thorough lymph node removal surgery, called "Template Lymph Node Dissection," can help prevent cancer from returning and help patients live longer, compared to removing only a few enlarged lymph nodes, in patients with high-risk kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer)
- What is being tested?
- Template Lymph Node Dissection and Selective Lymph Node Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- Age > 18 years.
- Candidate for radical nephrectomy with or without lymph node dissection.
- High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node >1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size >= 10cm; OR hematuria and/or local symptoms.
- Measurable disease as per RECIST v1.1.
- ECOG performance status of 0 or 1.
- Adequate bone marrow, renal, and hepatic function.
- For women and men of childbearing potential, agreement to use effective contraception during the study period.
Who cannot join
- Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.
- Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).
- Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.
- Preoperative imaging indicates unresectable regional lymph nodes.
- renal tumors or known hereditary RCC syndrome.
- Diagnosis of any other active malignancy within the past 5 years.
Show all 20Show fewer
- Active autoimmune disease or history of autoimmune disease.
- Use of immunosuppressive agents within 2 weeks prior to enrollment.
- Poorly controlled cardiac or clinical symptoms.
- Coagulopathy or bleeding tendency.
- Active gastrointestinal conditions with risk of bleeding or perforation.
- History of significant bleeding or thromboembolic events within specified timeframes.
- Active infection or unexplained fever >38.5°C.
- Abdominal fistula, gastrointestinal perforation, or abscess within 4 weeks prior.
- History of pulmonary fibrosis, interstitial lung disease, or severely impaired pulmonary function.
- Known immunodeficiency or active hepatitis.
- Participation in another clinical trial within 1 month.
- Known history of drug abuse or alcohol addiction.
- Inability or unwillingness to bear the self-paid portion of examination and treatment costs.
- Any condition that, in the investigator's judgment, may compromise patient safety or study conduct.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211
Changyi Quan, +86 22 88328607
About this study
Official title: Template Lymph Node Dissection for Tumor Control in High-Risk Renal Cell Carcinoma: A Prospective, Open-Label, Multicenter, Randomized Controlled Trial
The goal of this clinical trial is to learn if a more thorough lymph node removal surgery, called "Template Lymph Node Dissection," can help prevent cancer from returning and help patients live longer, compared to removing only a few enlarged lymph nodes, in patients with high-risk kidney cancer. The main questions it aims to answer are:
Do patients who receive template lymph node dissection live longer without their cancer returning (Disease-Free Survival)? Do patients who receive template lymph node dissection live longer overall (Overall Survival)? Is the more extensive lymph node surgery as safe as the limited surgery? Researchers will compare the Template Lymph Node Dissection group to the Limited Node Resection group to see the effects on cancer control and safety.
Read more
Participants will:
Be randomly assigned to one of the two surgical groups. Undergo surgery to remove their kidney and the assigned lymph nodes. Attend regular follow-up visits with imaging scans (like CT or MRI) for the first 5 years after surgery to monitor if the cancer returns.
Be followed for their overall survival status for up to 10 years.
Read the detailed description
Research Background:
Renal cell carcinoma (RCC) remains a significant urological malignancy with rising global incidence. Radical nephrectomy (RN) is the standard curative treatment for localized disease. The therapeutic value of lymph node dissection (LND) in RCC, however, remains controversial. The EORTC 30881 trial demonstrated no survival benefit for RN with LND in clinically node-negative (cN0) patients, leading to its omission in contemporary guidelines. However, this trial predominantly included low-risk patients with a low incidence of pathological nodal involvement (4.0%), rendering it underpowered to evaluate LND efficacy in high-risk populations. Conversely, robust retrospective evidence suggests that in patients with high-risk features-such as advanced T-stage, large tumor size, sarcomatoid differentiation, or venous thrombus-more extensive LND may confer a therapeutic benefit by eradicating micrometastatic disease and improving cancer-specific survival. The advent of effective adjuvant immunotherapy (e.g., pembrolizumab) further underscores the need for accurate nodal staging and re-evaluation of LND's role. This prospective, randomized controlled trial aims to definitively assess the oncological benefit and safety of template-based LND in a rigorously selected high-risk RCC cohort.
Research Objectives:
Primary Objectives:
To compare the impact of RN combined with template lymph node dissection versus RN alone on overall survival (OS) and disease-free survival (DFS) in patients with high-risk RCC.
To evaluate and compare the surgical safety profiles of both approaches, including perioperative complications (graded by Clavien-Dindo classification), operative time, intraoperative blood loss, and length of hospital stay.
Secondary Objectives:
To compare cancer-specific survival (CSS) between the two groups. To quantify the number of lymph nodes retrieved and the incidence of nodal metastases within predefined anatomical templates (renal hilum, para-aortic, paracaval, and interaortocaval regions).
Exploratory Objectives:
To identify molecular biomarkers predictive of nodal metastasis or prognosis using Bulk-RNA sequencing of prospectively collected tumor and blood samples.
To develop a predictive nomogram for lymph node metastasis integrating radiomic features from triple-phase abdominal CT, MRI, tumor characteristics, and clinical symptoms.
Study Methodology:
This is a prospective, open-label, multicenter, randomized controlled trial. A total of 220 eligible patients with high-risk RCC-defined as cT3-4N0-1M0 or M1 disease rendered no evidence of disease (NED) after local therapy-will be randomized in a 1:1 ratio.
Intervention Group (Arm A): Patients will undergo RN plus template LND. The template for left-sided tumors includes lymph nodes from the diaphragmatic crus to the aortic bifurcation (anterior and lateral to the aorta), including the renal hilar nodes. For right-sided tumors, the template extends from the hepatic edge of the inferior vena cava (IVC) to the iliac bifurcation, encompassing paracaval, precaval, and interaortocaval nodes, including the renal hilum.
Control Group (Arm B): Patients will undergo RN with resection only of radiologically or intraoperatively detected lymph nodes ≥1 cm.
Randomization will be performed centrally and stratified by clinical nodal status (cN0 vs. cN1), prior metastatic status (M0 vs. M1→NED), type of renal cell carcinoma (clear cell RCC vs. non-clear cell RCC), and participating center.
Surgical approach (open, laparoscopic, or robot-assisted) will be at the surgeon's discretion. Postoperative adjuvant therapy with toripalimab (an anti-PD-1 agent) may be offered per patient preference, with one cycle provided free of charge by the study.
Endpoints and Statistical Analysis:
Primary endpoints are DFS and OS. Secondary endpoints include CSS, nodal yield and metastatic rate, and safety. DFS is defined as the time from randomization to recurrence, second primary RCC, or death from any cause. OS is defined as time from randomization to death from any cause. Time-to-event endpoints will be analyzed using Kaplan-Meier methods and compared with the log-rank test. Cox proportional hazards models will be used for multivariable analysis. Categorical variables will be compared using chi-square tests, and continuous variables with t-tests. A sample size of 220 provides 90% power to detect a 21.5% absolute improvement in 5-year OS (76% vs. 54.5%) at a two-sided α of 0.05, accounting for a 10% dropout rate.
Innovation:
This study addresses a critical evidence gap by prospectively evaluating template LND in a meticulously defined high-risk RCC population, including those with M1 NED status-a subgroup with particularly poor prognosis. It employs a standardized, anatomically defined "template" LND to ensure surgical quality and consistency across multiple centers. Furthermore, the study integrates contemporary biomarker and radiomic analyses to explore predictive tools for nodal metastasis and prognosis, which could personalize future surgical and adjuvant strategies. By conducting this trial in the era of adjuvant immunotherapy, it will elucidate whether LND provides independent therapeutic benefit beyond its staging role.
- Conditions
- Renal Cell Carcinoma (Kidney Cancer)
- Being tested
- Template Lymph Node Dissection, Selective Lymph Node Resection
- Keywords
- Template Lymph Node Dissection, High-Risk Neoplasm, Randomized Controlled Trial, Surgical Oncology
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Template Lymph Node DissectionProcedure or surgery
A standardized surgical procedure to remove lymph nodes within defined anatomical boundaries during radical nephrectomy for kidney cancer. For left-sided tumors, this includes tissue anterior and lateral to the aorta from the diaphragmatic crus to the aortic bifurcation. For right-sided tumors, it includes tissue around the vena cava and between the vena cava and aorta from the liver edge to the iliac bifurcation. The renal hilar lymph tissue is always included.
Selective Lymph Node ResectionProcedure or surgery
A surgical approach during radical nephrectomy for kidney cancer where lymph nodes are removed only if they meet specific criteria: being larger than 1 cm on preoperative CT/MRI scans, or appearing grossly enlarged and suspicious to the surgeon during the operation. If no such nodes are identified, no lymph node dissection is performed.
| Study group | Role | What they receive |
|---|---|---|
| Template Lymph Node Dissection | Experimental | Patients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach based on the surgeon's expertise) combined with a standardized template lymph node dissection.
The template lymph node dissection is defined as follows:
For Left-sided Tumors: Removal of lymphatic tissue anterior and lateral to the abdominal aorta, extending from the diaphragmatic crus superiorly to the aortic bifurcation inferiorly, including the renal hilar lymph tissue.
For Right-sided Tumors: Removal of lymphatic tissue surrounding the inferior vena cava and in the interaortocaval space, extending from the liver edge of the vena cava superiorly to the iliac vein bifurcation inferiorly, including the renal hilar lymph tissue. Receives: Procedure: Template Lymph Node Dissection |
| Selective Lymph Node Resection | Active comparator | Patients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach). In this arm, only lymph nodes that are identified as >1 cm in the short axis on preoperative cross-sectional imaging (CT/MRI) OR are grossly enlarged and suspicious during the surgeon's intraoperative assessment will be resected. If no such nodes are identified preoperatively or intraoperatively, no formal lymph node dissection is performed. Receives: Procedure: Selective Lymph Node Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Time from randomization to the first documented disease recurrence (local, regional, or distant metastasis), occurrence of a second primary renal cell carcinoma, or death from any cause, whichever occurs first.
Measured: From randomization until the first occurrence of disease recurrence, second primary cancer, or death from any cause, assessed up to 10 years.
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: From randomization until death from any cause, assessed up to 10 years.
Incidence and Severity of Postoperative Complications (Perioperative Safety)
A composite measure to assess the safety of the surgical procedures, including:
- Incidence and severity of postoperative complications graded by Clavien-Dindo classification.
- Operative time (minutes).
- Estimated intraoperative blood loss (milliliters).
- Length of postoperative hospital stay (days).
Measured: From the date of surgery until 30 days post-operation.
Secondary outcomes (5)
Cancer-Specific Survival (CSS)
Time from randomization to death attributable to renal cell carcinoma. Deaths from other causes are censored.
Measured: From randomization until death from kidney cancer, assessed up to 10 years.
Absolute Number of Retrieved Lymph Nodes per Anatomic Template
The absolute number of lymph nodes retrieved from each of the predefined anatomical template regions: right renal hilum, suprarenal para-caval, infrarenal para-caval, left renal hilum, suprarenal para-aortic, and renal hilar para-aortic.
Measured: Assessed on the surgical pathology report, immediately after surgery (within approximately 4 weeks post-operation).
Pathological Nodal Positivity Rate (pN+%) per Anatomic Template
The pathological nodal positivity rate (calculated as the number of positive nodes divided by the total number of retrieved nodes, expressed as a percentage) from each of the predefined anatomical template regions.
Measured: Assessed on the surgical pathology report, immediately after surgery (within approximately 4 weeks post-operation).
Exploration of Biomarkers for Survival
Identification of molecular biomarkers predictive of Disease-Free Survival (DFS), Cancer-Specific Survival (CSS), and Overall Survival (OS) through Bulk-RNA sequencing analysis performed on prospectively collected tumor tissue samples.
Measured: Biomarker analysis will be conducted after sufficient clinical outcome data (DFS/OS events) are available, estimated to be 5 years after study start.
Predictive Nomogram for Lymph Node Metastasis
Development and validation of a predictive nomogram (statistical model) for preoperative estimation of lymph node metastasis risk. The model will integrate radiomic features from contrast-enhanced abdominal CT and non-contrast MRI, along with clinical variables (tumor size/location, retroperitoneal/renal hilar lymph node size/location, and clinical symptoms).
Measured: Model development and internal validation will be performed after complete recruitment and surgical pathology data are available for all participants, estimated to be 3 years after study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, Tianjin Medical University Cancer Institute and Hospital, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Tianjin Third Central Hospital
- Responsible party
- Sponsor
- Investigators
- Changyi Quan, MD, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321197
- Sponsor's protocol ID
- TLND-RCC
- Acronym
- RECLND
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.
PubMed 39817679Capitanio U, Matloob R, Suardi N, Abdollah F, Castiglione F, Di Trapani D, Russo A, Briganti A, Carenzi C, Salonia A, Montorsi F, Rigatti P, Bertini R. The extent of lymphadenectomy does affect cancer specific survival in pathologically confirmed T4 renal cell carcinoma. Urologia. 2012 Apr-Jun;79(2):109-15. doi: 10.5301/RU.2012.9255.
PubMed 22610843Capitanio U, Suardi N, Matloob R, Roscigno M, Abdollah F, Di Trapani E, Moschini M, Gallina A, Salonia A, Briganti A, Montorsi F, Bertini R. Extent of lymph node dissection at nephrectomy affects cancer-specific survival and metastatic progression in specific sub-categories of patients with renal cell carcinoma (RCC). BJU Int. 2014 Aug;114(2):210-5. doi: 10.1111/bju.12508. Epub 2014 May 22.
PubMed 24854206Whitson JM, Harris CR, Reese AC, Meng MV. Lymphadenectomy improves survival of patients with renal cell carcinoma and nodal metastases. J Urol. 2011 May;185(5):1615-20. doi: 10.1016/j.juro.2010.12.053. Epub 2011 Mar 21.
PubMed 21419453Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
PubMed 35020204Crispen PL, Breau RH, Allmer C, Lohse CM, Cheville JC, Leibovich BC, Blute ML. Lymph node dissection at the time of radical nephrectomy for high-risk clear cell renal cell carcinoma: indications and recommendations for surgical templates. Eur Urol. 2011 Jan;59(1):18-23. doi: 10.1016/j.eururo.2010.08.042. Epub 2010 Sep 15.
PubMed 20933322Motzer RJ, Jonasch E, Agarwal N, Alva A, Baine M, Beckermann K, Carlo MI, Choueiri TK, Costello BA, Derweesh IH, Desai A, Ged Y, George S, Gore JL, Haas N, Hancock SL, Kapur P, Kyriakopoulos C, Lam ET, Lara PN, Lau C, Lewis B, Madoff DC, Manley B, Michaelson MD, Mortazavi A, Nandagopal L, Plimack ER, Ponsky L, Ramalingam S, Shuch B, Smith ZL, Sosman J, Dwyer MA, Gurski LA, Motter A. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Jan;20(1):71-90. doi: 10.6004/jnccn.2022.0001.
PubMed 34991070Hutterer GC, Patard JJ, Perrotte P, Ionescu C, de La Taille A, Salomon L, Verhoest G, Tostain J, Cindolo L, Ficarra V, Artibani W, Schips L, Zigeuner R, Mulders PF, Valeri A, Chautard D, Descotes JL, Rambeaud JJ, Mejean A, Karakiewicz PI. Patients with renal cell carcinoma nodal metastases can be accurately identified: external validation of a new nomogram. Int J Cancer. 2007 Dec 1;121(11):2556-61. doi: 10.1002/ijc.23010.
PubMed 17691107Babaian KN, Kim DY, Kenney PA, Wood CG Jr, Wong J, Sanchez C, Fang JE, Gerber JA, Didic A, Wahab A, Golla V, Torres C, Tamboli P, Qiao W, Matin SF, Wood CG, Karam JA. Preoperative predictors of pathological lymph node metastasis in patients with renal cell carcinoma undergoing retroperitoneal lymph node dissection. J Urol. 2015 Apr;193(4):1101-7. doi: 10.1016/j.juro.2014.10.096. Epub 2014 Oct 25.
PubMed 25390078Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Chang YH, Lee JL, Sarwar N, Haas NB, Gurney H, Sawrycki P, Mahave M, Gross-Goupil M, Zhang T, Burke JM, Doshi G, Melichar B, Kopyltsov E, Alva A, Oudard S, Topart D, Hammers H, Kitamura H, McDermott DF, Silva A, Winquist E, Cornell J, Elfiky A, Burgents JE, Perini RF, Powles T; KEYNOTE-564 Investigators. Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma. N Engl J Med. 2024 Apr 18;390(15):1359-1371. doi: 10.1056/NEJMoa2312695.
PubMed 38631003Margulis V, Wood CG. The role of lymph node dissection in renal cell carcinoma: the pendulum swings back. Cancer J. 2008 Sep-Oct;14(5):308-14. doi: 10.1097/PPO.0b013e31818675eb.
PubMed 18836335Gershman B, Moreira DM, Thompson RH, Boorjian SA, Lohse CM, Costello BA, Cheville JC, Leibovich BC. Perioperative Morbidity of Lymph Node Dissection for Renal Cell Carcinoma: A Propensity Score-based Analysis. Eur Urol. 2018 Mar;73(3):469-475. doi: 10.1016/j.eururo.2017.10.020. Epub 2017 Nov 11.
PubMed 29132713Bex A, Ghanem YA, Albiges L, Bonn S, Campi R, Capitanio U, Dabestani S, Hora M, Klatte T, Kuusk T, Lund L, Marconi L, Palumbo C, Pignot G, Powles T, Schouten N, Tran M, Volpe A, Bedke J. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2025 Update. Eur Urol. 2025 Jun;87(6):683-696. doi: 10.1016/j.eururo.2025.02.020. Epub 2025 Mar 20.
PubMed 40118739Pantuck AJ, Zisman A, Dorey F, Chao DH, Han KR, Said J, Gitlitz BJ, Figlin RA, Belldegrun AS. Renal cell carcinoma with retroperitoneal lymph nodes: role of lymph node dissection. J Urol. 2003 Jun;169(6):2076-83. doi: 10.1097/01.ju.0000066130.27119.1c.
PubMed 12771723Gershman B, Thompson RH, Moreira DM, Boorjian SA, Tollefson MK, Lohse CM, Costello BA, Cheville JC, Leibovich BC. Radical Nephrectomy With or Without Lymph Node Dissection for Nonmetastatic Renal Cell Carcinoma: A Propensity Score-based Analysis. Eur Urol. 2017 Apr;71(4):560-567. doi: 10.1016/j.eururo.2016.09.019. Epub 2016 Sep 24.
PubMed 27671144
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Template Lymph Node Dissection for Tumor Control in High-Risk Renal Cell Carcinoma: A Prospective, Open-Label, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07321197
- Acronym / sponsor ID
- RECLND / TLND-RCC
- Conditions
- Renal Cell Carcinoma (Kidney Cancer)
- Keywords
- Template Lymph Node Dissection, High-Risk Neoplasm, Randomized Controlled Trial, Surgical Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, Tianjin Medical University Cancer Institute and Hospital, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Tianjin Third Central Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a more thorough lymph node removal surgery, called "Template Lymph Node Dissection," can help prevent cancer from returning and help patients live longer, compared to removing only a few enlarged lymph nodes, in patients with high-risk kidney cancer. The main questions it aims to answer are:
Do patients who receive template lymph node dissection live longer without their cancer returning (Disease-Free Survival)? Do patients who receive template lymph node dissection live longer overall (Overall Survival)? Is the more extensive lymph node surgery as safe as the limited surgery? Researchers will compare the Template Lymph Node Dissection group to the Limited Node Resection group to see the effects on cancer control and safety.
Participants will:
Be randomly assigned to one of the two surgical groups. Undergo surgery to remove their kidney and the assigned lymph nodes. Attend regular follow-up visits with imaging scans (like CT or MRI) for the first 5 years after surgery to monitor if the cancer returns.
Be followed for their overall survival status for up to 10 years.
Detailed description
Research Background:
Renal cell carcinoma (RCC) remains a significant urological malignancy with rising global incidence. Radical nephrectomy (RN) is the standard curative treatment for localized disease. The therapeutic value of lymph node dissection (LND) in RCC, however, remains controversial. The EORTC 30881 trial demonstrated no survival benefit for RN with LND in clinically node-negative (cN0) patients, leading to its omission in contemporary guidelines. However, this trial predominantly included low-risk patients with a low incidence of pathological nodal involvement (4.0%), rendering it underpowered to evaluate LND efficacy in high-risk populations. Conversely, robust retrospective evidence suggests that in patients with high-risk features-such as advanced T-stage, large tumor size, sarcomatoid differentiation, or venous thrombus-more extensive LND may confer a therapeutic benefit by eradicating micrometastatic disease and improving cancer-specific survival. The advent of effective adjuvant immunotherapy (e.g., pembrolizumab) further underscores the need for accurate nodal staging and re-evaluation of LND's role. This prospective, randomized controlled trial aims to definitively assess the oncological benefit and safety of template-based LND in a rigorously selected high-risk RCC cohort.
Research Objectives:
Primary Objectives:
To compare the impact of RN combined with template lymph node dissection versus RN alone on overall survival (OS) and disease-free survival (DFS) in patients with high-risk RCC.
To evaluate and compare the surgical safety profiles of both approaches, including perioperative complications (graded by Clavien-Dindo classification), operative time, intraoperative blood loss, and length of hospital stay.
Secondary Objectives:
To compare cancer-specific survival (CSS) between the two groups. To quantify the number of lymph nodes retrieved and the incidence of nodal metastases within predefined anatomical templates (renal hilum, para-aortic, paracaval, and interaortocaval regions).
Exploratory Objectives:
To identify molecular biomarkers predictive of nodal metastasis or prognosis using Bulk-RNA sequencing of prospectively collected tumor and blood samples.
To develop a predictive nomogram for lymph node metastasis integrating radiomic features from triple-phase abdominal CT, MRI, tumor characteristics, and clinical symptoms.
Study Methodology:
This is a prospective, open-label, multicenter, randomized controlled trial. A total of 220 eligible patients with high-risk RCC-defined as cT3-4N0-1M0 or M1 disease rendered no evidence of disease (NED) after local therapy-will be randomized in a 1:1 ratio.
Intervention Group (Arm A): Patients will undergo RN plus template LND. The template for left-sided tumors includes lymph nodes from the diaphragmatic crus to the aortic bifurcation (anterior and lateral to the aorta), including the renal hilar nodes. For right-sided tumors, the template extends from the hepatic edge of the inferior vena cava (IVC) to the iliac bifurcation, encompassing paracaval, precaval, and interaortocaval nodes, including the renal hilum.
Control Group (Arm B): Patients will undergo RN with resection only of radiologically or intraoperatively detected lymph nodes ≥1 cm.
Randomization will be performed centrally and stratified by clinical nodal status (cN0 vs. cN1), prior metastatic status (M0 vs. M1→NED), type of renal cell carcinoma (clear cell RCC vs. non-clear cell RCC), and participating center.
Surgical approach (open, laparoscopic, or robot-assisted) will be at the surgeon's discretion. Postoperative adjuvant therapy with toripalimab (an anti-PD-1 agent) may be offered per patient preference, with one cycle provided free of charge by the study.
Endpoints and Statistical Analysis:
Primary endpoints are DFS and OS. Secondary endpoints include CSS, nodal yield and metastatic rate, and safety. DFS is defined as the time from randomization to recurrence, second primary RCC, or death from any cause. OS is defined as time from randomization to death from any cause. Time-to-event endpoints will be analyzed using Kaplan-Meier methods and compared with the log-rank test. Cox proportional hazards models will be used for multivariable analysis. Categorical variables will be compared using chi-square tests, and continuous variables with t-tests. A sample size of 220 provides 90% power to detect a 21.5% absolute improvement in 5-year OS (76% vs. 54.5%) at a two-sided α of 0.05, accounting for a 10% dropout rate.
Innovation:
This study addresses a critical evidence gap by prospectively evaluating template LND in a meticulously defined high-risk RCC population, including those with M1 NED status-a subgroup with particularly poor prognosis. It employs a standardized, anatomically defined "template" LND to ensure surgical quality and consistency across multiple centers. Furthermore, the study integrates contemporary biomarker and radiomic analyses to explore predictive tools for nodal metastasis and prognosis, which could personalize future surgical and adjuvant strategies. By conducting this trial in the era of adjuvant immunotherapy, it will elucidate whether LND provides independent therapeutic benefit beyond its staging role.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Template Lymph Node Dissection | Experimental | Procedure: Template Lymph Node DissectionPatients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach based on the surgeon's expertise) combined with a standardized template lymph node dissection. The template lymph node dissection is defined as follows: For Left-sided Tumors: Removal of lymphatic tissue anterior and lateral to the abdominal aorta, extending from the diaphragmatic crus superiorly to the aortic bifurcation inferiorly, including the renal hilar lymph tissue. For Right-sided Tumors: Removal of lymphatic tissue surrounding the inferior vena cava and in the interaortocaval space, extending from the liver edge of the vena cava superiorly to the iliac vein bifurcation inferiorly, including the renal hilar lymph tissue. |
| Selective Lymph Node Resection | Active comparator | Procedure: Selective Lymph Node ResectionPatients randomized to this arm will undergo radical nephrectomy (which may be performed via open, laparoscopic, or robot-assisted approach). In this arm, only lymph nodes that are identified as >1 cm in the short axis on preoperative cross-sectional imaging (CT/MRI) OR are grossly enlarged and suspicious during the surgeon's intraoperative assessment will be resected. If no such nodes are identified preoperatively or intraoperatively, no formal lymph node dissection is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent form.
- Age > 18 years.
- Candidate for radical nephrectomy with or without lymph node dissection.
- High-risk renal cell carcinoma defined as: At least ONE of: Clinical stage cT3-4 N0-1 M0 (AJCC 8th ed); OR radiologically visible lymph node >1cm; OR M1 disease rendered no evidence of disease (NED) after local therapy; OR radiologically determined rT4 stage. OR at least TWO of: Renal vein or inferior vena cava tumor thrombus; OR nuclear grade 3-4 or sarcomatoid differentiation or coagulative necrosis; OR tumor size >= 10cm; OR hematuria and/or local symptoms.
- Measurable disease as per RECIST v1.1.
Key exclusion criteria (20 listed)
- Prior radiotherapy, chemotherapy, major surgery, or targeted therapy for RCC.
- Concurrent other active malignancy (except controlled malignancies not affecting 2-year survival).
- Candidate for partial nephrectomy or ablation per multidisciplinary team assessment.
- Preoperative imaging indicates unresectable regional lymph nodes.
- renal tumors or known hereditary RCC syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Template Lymph Node DissectionA standardized surgical procedure to remove lymph nodes within defined anatomical boundaries during radical nephrectomy for kidney cancer. For left-sided tumors, this includes tissue anterior and lateral to the aorta from the diaphragmatic crus to the aortic bifurcation. For right-sided tumors, it includes tissue around the vena cava and between the vena cava and aorta from the liver edge to the iliac bifurcation. The renal hilar lymph tissue is always included. | Procedure or surgery | Template Lymph Node Dissection |
| Selective Lymph Node ResectionA surgical approach during radical nephrectomy for kidney cancer where lymph nodes are removed only if they meet specific criteria: being larger than 1 cm on preoperative CT/MRI scans, or appearing grossly enlarged and suspicious to the surgeon during the operation. If no such nodes are identified, no lymph node dissection is performed. | Procedure or surgery | Selective Lymph Node Resection |
Primary outcome
Disease-Free Survival (DFS)
Time frame: From randomization until the first occurrence of disease recurrence, second primary cancer, or death from any cause, assessed up to 10 years.
Time from randomization to the first documented disease recurrence (local, regional, or distant metastasis), occurrence of a second primary renal cell carcinoma, or death from any cause, whichever occurs first.
Overall Survival (OS)
Time frame: From randomization until death from any cause, assessed up to 10 years.
Time from randomization to death from any cause.
Incidence and Severity of Postoperative Complications (Perioperative Safety)
Time frame: From the date of surgery until 30 days post-operation.
A composite measure to assess the safety of the surgical procedures, including: 1. Incidence and severity of postoperative complications graded by Clavien-Dindo classification. 2. Operative time (minutes). 3. Estimated intraoperative blood loss (milliliters). 4. Length of postoperative hospital stay (days).
5 secondary outcomes
Cancer-Specific Survival (CSS)
Time frame: From randomization until death from kidney cancer, assessed up to 10 years.
Absolute Number of Retrieved Lymph Nodes per Anatomic Template
Time frame: Assessed on the surgical pathology report, immediately after surgery (within approximately 4 weeks post-operation).
Pathological Nodal Positivity Rate (pN+%) per Anatomic Template
Time frame: Assessed on the surgical pathology report, immediately after surgery (within approximately 4 weeks post-operation).
Exploration of Biomarkers for Survival
Time frame: Biomarker analysis will be conducted after sufficient clinical outcome data (DFS/OS events) are available, estimated to be 5 years after study start.
Predictive Nomogram for Lymph Node Metastasis
Time frame: Model development and internal validation will be performed after complete recruitment and surgical pathology data are available for all participants, estimated to be 3 years after study start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 39817679Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.
- Background: PubMed 22610843Capitanio U, Matloob R, Suardi N, Abdollah F, Castiglione F, Di Trapani D, Russo A, Briganti A, Carenzi C, Salonia A, Montorsi F, Rigatti P, Bertini R. The extent of lymphadenectomy does affect cancer specific survival in pathologically confirmed T4 renal cell carcinoma. Urologia. 2012 Apr-Jun;79(2):109-15. doi: 10.5301/RU.2012.9255.
- Background: PubMed 24854206Capitanio U, Suardi N, Matloob R, Roscigno M, Abdollah F, Di Trapani E, Moschini M, Gallina A, Salonia A, Briganti A, Montorsi F, Bertini R. Extent of lymph node dissection at nephrectomy affects cancer-specific survival and metastatic progression in specific sub-categories of patients with renal cell carcinoma (RCC). BJU Int. 2014 Aug;114(2):210-5. doi: 10.1111/bju.12508. Epub 2014 May 22.
- Background: PubMed 21419453Whitson JM, Harris CR, Reese AC, Meng MV. Lymphadenectomy improves survival of patients with renal cell carcinoma and nodal metastases. J Urol. 2011 May;185(5):1615-20. doi: 10.1016/j.juro.2010.12.053. Epub 2011 Mar 21.
- Background: PubMed 35020204Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
- Background: PubMed 20933322Crispen PL, Breau RH, Allmer C, Lohse CM, Cheville JC, Leibovich BC, Blute ML. Lymph node dissection at the time of radical nephrectomy for high-risk clear cell renal cell carcinoma: indications and recommendations for surgical templates. Eur Urol. 2011 Jan;59(1):18-23. doi: 10.1016/j.eururo.2010.08.042. Epub 2010 Sep 15.
- Background: PubMed 34991070Motzer RJ, Jonasch E, Agarwal N, Alva A, Baine M, Beckermann K, Carlo MI, Choueiri TK, Costello BA, Derweesh IH, Desai A, Ged Y, George S, Gore JL, Haas N, Hancock SL, Kapur P, Kyriakopoulos C, Lam ET, Lara PN, Lau C, Lewis B, Madoff DC, Manley B, Michaelson MD, Mortazavi A, Nandagopal L, Plimack ER, Ponsky L, Ramalingam S, Shuch B, Smith ZL, Sosman J, Dwyer MA, Gurski LA, Motter A. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Jan;20(1):71-90. doi: 10.6004/jnccn.2022.0001.
- Background: PubMed 17691107Hutterer GC, Patard JJ, Perrotte P, Ionescu C, de La Taille A, Salomon L, Verhoest G, Tostain J, Cindolo L, Ficarra V, Artibani W, Schips L, Zigeuner R, Mulders PF, Valeri A, Chautard D, Descotes JL, Rambeaud JJ, Mejean A, Karakiewicz PI. Patients with renal cell carcinoma nodal metastases can be accurately identified: external validation of a new nomogram. Int J Cancer. 2007 Dec 1;121(11):2556-61. doi: 10.1002/ijc.23010.
- Background: PubMed 25390078Babaian KN, Kim DY, Kenney PA, Wood CG Jr, Wong J, Sanchez C, Fang JE, Gerber JA, Didic A, Wahab A, Golla V, Torres C, Tamboli P, Qiao W, Matin SF, Wood CG, Karam JA. Preoperative predictors of pathological lymph node metastasis in patients with renal cell carcinoma undergoing retroperitoneal lymph node dissection. J Urol. 2015 Apr;193(4):1101-7. doi: 10.1016/j.juro.2014.10.096. Epub 2014 Oct 25.
- Background: PubMed 38631003Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Chang YH, Lee JL, Sarwar N, Haas NB, Gurney H, Sawrycki P, Mahave M, Gross-Goupil M, Zhang T, Burke JM, Doshi G, Melichar B, Kopyltsov E, Alva A, Oudard S, Topart D, Hammers H, Kitamura H, McDermott DF, Silva A, Winquist E, Cornell J, Elfiky A, Burgents JE, Perini RF, Powles T; KEYNOTE-564 Investigators. Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma. N Engl J Med. 2024 Apr 18;390(15):1359-1371. doi: 10.1056/NEJMoa2312695.
- Background: PubMed 18836335Margulis V, Wood CG. The role of lymph node dissection in renal cell carcinoma: the pendulum swings back. Cancer J. 2008 Sep-Oct;14(5):308-14. doi: 10.1097/PPO.0b013e31818675eb.
- Background: PubMed 29132713Gershman B, Moreira DM, Thompson RH, Boorjian SA, Lohse CM, Costello BA, Cheville JC, Leibovich BC. Perioperative Morbidity of Lymph Node Dissection for Renal Cell Carcinoma: A Propensity Score-based Analysis. Eur Urol. 2018 Mar;73(3):469-475. doi: 10.1016/j.eururo.2017.10.020. Epub 2017 Nov 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Changyi Quan, MD principal investigator
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Template Lymph Node Dissection and Selective Lymph Node Resection in people with Renal Cell Carcinoma (Kidney Cancer), run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shimiao Zhu, MD, PhD (+86 88328607, zhushimiao@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: From randomization until the first occurrence of disease recurrence, second primary cancer, or death from any cause, assessed up to 10 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07321197, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.