Gastric AdenocarcinomaPhase 2PAN-SELECTNCT07912606
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
A Phase 2 study testing Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection and Gastrectomy with standard D2 lymphadenectomy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Some patients with gastric cancer have enlarged para-aortic lymph nodes, also called No. 16 lymph nodes, at diagnosis. After standard chemoimmunotherapy, these lymph nodes may shrink to less than 10 mm on imaging, but it is uncertain whether microscopic cancer remains and whether surgically removing these nodes… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection and Gastrectomy with standard D2 lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Dec 2034
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years.
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma limited to Siewert type III or Siewert type II disease not requiring a transthoracic combined operation.
- Human epidermal growth factor receptor 2 (HER2)-negative disease, defined as immunohistochemistry 0 or 1+, or immunohistochemistry 2+ with negative fluorescence in situ hybridization, or HER2 status unknown.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- At initial diagnosis, thin-section contrast-enhanced computed tomography shows at least one No. 16a2 and/or No. 16b1 lymph node with a short-axis diameter of at least 10 mm and metastatic morphology, such as a round shape, irregular border, central necrosis, clustering, or abnormal enhancement, confirmed by two radiologists or gastric cancer multidisciplinary team physicians with relevant experience.
- Regional lymph node metastases are permitted, but imaging shows no peritoneal, hepatic, pulmonary, osseous, or other distant metastasis apart from the eligible No. 16a2 and/or No. 16b1 lymph nodes.
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- Completion of 2 to 8 cycles of an immune checkpoint inhibitor combined with chemotherapy as routine clinical care before randomization, with the agents, doses, modifications, and number of cycles determined by the multidisciplinary team and completely documented.
- At the first reassessment after completion of the planned preoperative systemic therapy, all previously suspicious No. 16a2 and No. 16b1 lymph nodes have a short-axis diameter of less than 10 mm.
- No disease progression according to RECIST version 1.1 and clinical assessment, and no new distant metastasis at the post-treatment reassessment.
- The gastric primary tumor and regional disease are considered resectable with curative intent and an R0 resection is expected; the participant is considered medically and technically eligible for either assigned operation.
- Toxicities related to the last preoperative systemic therapy have recovered to Common Terminology Criteria for Adverse Events version 5.0 grade 1 or lower or to the pretreatment baseline. Controlled immune-related endocrine events requiring only stable replacement therapy are permitted.
- Adequate major organ function, cardiopulmonary reserve, and acceptable anesthetic risk for gastrectomy and possible para-aortic lymph node dissection.
- Ability and willingness to complete study follow-up and provide written informed consent after post-treatment eligibility is confirmed.
Who cannot join
- Disease progression, a new distant metastasis, or any suspicious para-aortic lymph node with a short-axis diameter of 10 mm or greater at the post-treatment reassessment.
- Curative-intent R0 resection is not considered feasible, or the participant cannot tolerate both assigned surgical strategies.
- Previous radical gastric cancer surgery or para-aortic operation expected to substantially alter the planned lymphadenectomy, or severe intra-abdominal adhesions or another condition that prevents safe completion of the assigned surgery.
- Uncontrolled active infection, severe cardiac, pulmonary, hepatic, or renal dysfunction, coagulopathy, or another disease that materially increases perioperative risk.
- Preoperative treatment toxicity has not recovered to the allowed level, or an unstable immune-related adverse event requires high-dose systemic immunosuppression.
- Pregnancy or breastfeeding, or inability to comply with clinically required contraception or follow-up.
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- Another active malignancy within the previous 5 years, except a cured malignancy with a low risk of recurrence as determined by the investigator and applicable ethics requirements.
- Concurrent participation in another interventional study that may interfere with evaluation of the primary outcome.
- Any other condition that, in the investigator's judgment, makes participation inappropriate.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: D2 Lymphadenectomy With Versus Without Para-Aortic Lymph Node Dissection in Gastric Cancer Patients With Radiologic Regression of Para-Aortic Lymph Nodes After Chemoimmunotherapy: A Single-Center Randomized Exploratory Trial
Some patients with gastric cancer have enlarged para-aortic lymph nodes, also called No. 16 lymph nodes, at diagnosis. After standard chemoimmunotherapy, these lymph nodes may shrink to less than 10 mm on imaging, but it is uncertain whether microscopic cancer remains and whether surgically removing these nodes improves disease control. This single-center randomized exploratory trial will enroll 32 patients whose suspicious No. 16a2 and/or No. 16b1 lymph nodes have regressed to less than 10 mm after 2 to 8 cycles of standard chemoimmunotherapy and who have no disease progression or new distant metastases. Participants will be assigned 1:1 to curative-intent gastrectomy with standard D2 lymphadenectomy either with or without para-aortic lymph node dissection. The main outcome is progression-free survival at 2 years after randomization.
Read the detailed description
PAN-SELECT is a prospective, open-label, parallel-group, single-center randomized exploratory trial. The study evaluates whether adding dissection of the No. 16a2 and No. 16b1 para-aortic lymph nodes to curative-intent gastrectomy and standard D2 lymphadenectomy improves outcomes in a response-selected population with gastric or eligible esophagogastric junction adenocarcinoma.
At initial diagnosis, eligible candidates must have radiologic evidence of involvement of No. 16a2 and/or No. 16b1 lymph nodes, defined by a short-axis diameter of at least 10 mm together with metastatic morphology, and no other distant metastases. Candidates receive 2 to 8 cycles of an immune checkpoint inhibitor combined with chemotherapy as routine clinical care outside the randomized intervention. The specific agents, doses, modifications, and number of cycles are selected by the multidisciplinary team according to current clinical practice and are recorded by the study.
After completion of the planned preoperative systemic therapy, chest, abdominal, and pelvic contrast-enhanced computed tomography is performed. Written informed consent for PAN-SELECT is obtained only after the first planned post-treatment reassessment confirms that all previously suspicious No. 16a2 and No. 16b1 lymph nodes have a short-axis diameter of less than 10 mm, there is no progression according to RECIST version 1.1 and clinical assessment, there is no new distant metastasis, curative-intent R0 resection appears feasible, and the patient is fit for either study operation.
After all randomization criteria are verified, an independent statistician-generated sequence using simple randomization with a fixed seed assigns participants 1:1 to one of two groups. The experimental group undergoes gastrectomy with standard D2 lymphadenectomy plus systematic dissection of No. 16a2 and No. 16b1 para-aortic lymph nodes. The active comparator group undergoes gastrectomy with standard D2 lymphadenectomy without planned systematic No. 16 dissection. Robotic, laparoscopic, and open approaches are permitted. Surgery is planned 2 to 6 weeks after the last preoperative systemic treatment, after treatment-related toxicity has recovered and the participant is clinically fit.
Participants and surgeons are not masked because the surgical fields differ. Radiologic progression and recurrence are independently assessed by two radiologists who are not involved in clinical decision-making and are unaware of treatment assignment; disagreement is resolved by a third radiologist or multidisciplinary review. Pathology reporting includes ypTNM stage, Becker or College of American Pathologists tumor regression grade, margin and R0 status, and regional lymph node station-specific counts. In the experimental group, the No. 16 specimen is submitted separately and the number of examined and metastatic No. 16 lymph nodes is recorded.
The primary estimand is the between-group difference in 2-year progression-free survival under the intention-to-treat principle. The sample size of 32 participants is based on single-center feasibility and the precision needed for preliminary estimates rather than a formal superiority or noninferiority hypothesis test. Results will be used to estimate effect size, event rates, surgical safety, protocol adherence, and recruitment feasibility for a future multicenter confirmatory trial.
- Being tested
- Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection, Gastrectomy with standard D2 lymphadenectomy
- Keywords
- Para-Aortic Lymph Node Metastasis, No. 16 Lymph Node, Para-Aortic Lymph Node Dissection, D2 Lymphadenectomy, Chemoimmunotherapy, Gastric Cancer, Randomized Exploratory Trial
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissectionProcedure or surgery
Distal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and additional systematic dissection of No. 16a2 from the upper border of the celiac trunk to the lower border of the left renal vein and No. 16b1 from the lower border of the left renal vein to the upper border of the inferior mesenteric artery. Robotic, laparoscopic, or open surgery is permitted.
Gastrectomy with standard D2 lymphadenectomyProcedure or surgery
Distal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and without planned systematic No. 16a2 or No. 16b1 dissection. Robotic, laparoscopic, or open surgery is permitted.
| Study group | Role | What they receive |
|---|---|---|
| D2 plus PAND | Experimental | Participants undergo curative-intent gastrectomy with standard D2 lymphadenectomy plus systematic para-aortic lymph node dissection of No. 16a2 and No. 16b1. The No. 16 specimen is submitted separately for pathological examination. Receives: Procedure: Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection |
| D2 alone | Experimental | Participants undergo curative-intent gastrectomy with standard D2 lymphadenectomy without planned systematic dissection of No. 16a2 or No. 16b1. Rescue removal or dissection is permitted only when an intraoperative finding requires treatment for safety or curative intent, and the reason and extent are recorded. Receives: Procedure: Gastrectomy with standard D2 lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate at 2 years
Progression-free survival is measured from randomization to the earliest of radiologic or clinical disease progression, postoperative local, regional, or distant recurrence, or death from any cause. Participants without an event are censored at the date of their last adequate disease assessment. The 2-year progression-free survival rate will be estimated by the Kaplan-Meier method.
Measured: From randomization to 2 years after randomization
Secondary outcomes (12)
Recurrence-free survival rate at 2 years after surgery
Among participants who undergo R0 resection, recurrence-free survival is measured from surgery to the earliest of local, regional, or distant recurrence or death from any cause. Participants without an event are censored at the date of their last adequate disease assessment.
Measured: From surgery to 2 years after surgery
Overall survival
Overall survival is measured from randomization to death from any cause. Participants alive at the last follow-up are censored on that date.
Measured: From randomization through 5 years after surgery
Cumulative incidence of para-aortic lymph node region recurrence
Recurrence involving the No. 16a2 or No. 16b1 region is determined by imaging, pathology, or clinical evidence. The cumulative incidence will be estimated with death without para-aortic recurrence treated as a competing event, and recurrence patterns will be summarized.
Measured: From randomization through 5 years after surgery
R0 resection rate
The percentage of randomized participants with microscopically negative proximal, distal, and applicable circumferential or other resection margins.
Measured: At definitive postoperative pathological assessment, generally within 30 days after surgery
Pathological complete response rate
The percentage of participants with no residual viable tumor in the gastric primary tumor and all evaluated lymph nodes, defined as ypT0N0.
Measured: At definitive postoperative pathological assessment, generally within 30 days after surgery
Number of examined and metastatic regional lymph nodes
Regional lymph nodes will be recorded by station, including the number examined and the number with pathologically confirmed metastasis.
Measured: At definitive postoperative pathological assessment, generally within 30 days after surgery
Pathological positivity rate of No. 16 para-aortic lymph nodes in the experimental arm
Among participants assigned to D2 lymphadenectomy plus para-aortic lymph node dissection who have an evaluable No. 16 specimen, the percentage with at least one pathologically metastatic No. 16 lymph node and the numbers examined and metastatic will be reported.
Measured: At definitive postoperative pathological assessment, generally within 30 days after surgery
Operative time
Operative time in minutes, measured according to the institutional anesthesia and operative record, will be summarized by randomized group.
Measured: During the assigned surgery
Estimated intraoperative blood loss
Estimated blood loss in milliliters, as recorded in the operative and anesthesia records, will be summarized by randomized group.
Measured: During the assigned surgery
Postoperative length of hospital stay
The number of days from surgery to hospital discharge will be summarized by randomized group.
Measured: From surgery until discharge, generally within 30 days after surgery
Rate of Clavien-Dindo grade III or higher postoperative complications
The percentage of participants with at least one postoperative complication requiring surgical, endoscopic, or radiologic intervention, intensive care for organ dysfunction, or resulting in death, classified as Clavien-Dindo grade III or higher.
Measured: Within 30 days after surgery
All-cause postoperative mortality
The percentage of participants who die from any cause within 90 days after surgery.
Measured: Within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2031 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Hao Xu, MD, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912606
- Sponsor's protocol ID
- FNMU-PAN-SELECT-2026-01
- Acronym
- PAN-SELECT
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethic restriction.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D2 Lymphadenectomy With Versus Without Para-Aortic Lymph Node Dissection in Gastric Cancer Patients With Radiologic Regression of Para-Aortic Lymph Nodes After Chemoimmunotherapy: A Single-Center Randomized Exploratory Trial
- ClinicalTrials.gov ID
- NCT07912606
- Acronym / sponsor ID
- PAN-SELECT / FNMU-PAN-SELECT-2026-01
- Keywords
- Para-Aortic Lymph Node Metastasis, No. 16 Lymph Node, Para-Aortic Lymph Node Dissection, D2 Lymphadenectomy, Chemoimmunotherapy, Gastric Cancer, Randomized Exploratory Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2031 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 3 Nov 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.
Some patients with gastric cancer have enlarged para-aortic lymph nodes, also called No. 16 lymph nodes, at diagnosis. After standard chemoimmunotherapy, these lymph nodes may shrink to less than 10 mm on imaging, but it is uncertain whether microscopic cancer remains and whether surgically removing these nodes improves disease control. This single-center randomized exploratory trial will enroll 32 patients whose suspicious No. 16a2 and/or No. 16b1 lymph nodes have regressed to less than 10 mm after 2 to 8 cycles of standard chemoimmunotherapy and who have no disease progression or new distant metastases. Participants will be assigned 1:1 to curative-intent gastrectomy with standard D2 lymphadenectomy either with or without para-aortic lymph node dissection. The main outcome is progression-free survival at 2 years after randomization.
Detailed description
PAN-SELECT is a prospective, open-label, parallel-group, single-center randomized exploratory trial. The study evaluates whether adding dissection of the No. 16a2 and No. 16b1 para-aortic lymph nodes to curative-intent gastrectomy and standard D2 lymphadenectomy improves outcomes in a response-selected population with gastric or eligible esophagogastric junction adenocarcinoma.
At initial diagnosis, eligible candidates must have radiologic evidence of involvement of No. 16a2 and/or No. 16b1 lymph nodes, defined by a short-axis diameter of at least 10 mm together with metastatic morphology, and no other distant metastases. Candidates receive 2 to 8 cycles of an immune checkpoint inhibitor combined with chemotherapy as routine clinical care outside the randomized intervention. The specific agents, doses, modifications, and number of cycles are selected by the multidisciplinary team according to current clinical practice and are recorded by the study.
After completion of the planned preoperative systemic therapy, chest, abdominal, and pelvic contrast-enhanced computed tomography is performed. Written informed consent for PAN-SELECT is obtained only after the first planned post-treatment reassessment confirms that all previously suspicious No. 16a2 and No. 16b1 lymph nodes have a short-axis diameter of less than 10 mm, there is no progression according to RECIST version 1.1 and clinical assessment, there is no new distant metastasis, curative-intent R0 resection appears feasible, and the patient is fit for either study operation.
After all randomization criteria are verified, an independent statistician-generated sequence using simple randomization with a fixed seed assigns participants 1:1 to one of two groups. The experimental group undergoes gastrectomy with standard D2 lymphadenectomy plus systematic dissection of No. 16a2 and No. 16b1 para-aortic lymph nodes. The active comparator group undergoes gastrectomy with standard D2 lymphadenectomy without planned systematic No. 16 dissection. Robotic, laparoscopic, and open approaches are permitted. Surgery is planned 2 to 6 weeks after the last preoperative systemic treatment, after treatment-related toxicity has recovered and the participant is clinically fit.
Participants and surgeons are not masked because the surgical fields differ. Radiologic progression and recurrence are independently assessed by two radiologists who are not involved in clinical decision-making and are unaware of treatment assignment; disagreement is resolved by a third radiologist or multidisciplinary review. Pathology reporting includes ypTNM stage, Becker or College of American Pathologists tumor regression grade, margin and R0 status, and regional lymph node station-specific counts. In the experimental group, the No. 16 specimen is submitted separately and the number of examined and metastatic No. 16 lymph nodes is recorded.
The primary estimand is the between-group difference in 2-year progression-free survival under the intention-to-treat principle. The sample size of 32 participants is based on single-center feasibility and the precision needed for preliminary estimates rather than a formal superiority or noninferiority hypothesis test. Results will be used to estimate effect size, event rates, surgical safety, protocol adherence, and recruitment feasibility for a future multicenter confirmatory trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 plus PAND | Experimental | Procedure: Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissectionParticipants undergo curative-intent gastrectomy with standard D2 lymphadenectomy plus systematic para-aortic lymph node dissection of No. 16a2 and No. 16b1. The No. 16 specimen is submitted separately for pathological examination. |
| D2 alone | Experimental | Procedure: Gastrectomy with standard D2 lymphadenectomyParticipants undergo curative-intent gastrectomy with standard D2 lymphadenectomy without planned systematic dissection of No. 16a2 or No. 16b1. Rescue removal or dissection is permitted only when an intraoperative finding requires treatment for safety or curative intent, and the reason and extent are recorded. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 to 75 years.
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma limited to Siewert type III or Siewert type II disease not requiring a transthoracic combined operation.
- Human epidermal growth factor receptor 2 (HER2)-negative disease, defined as immunohistochemistry 0 or 1+, or immunohistochemistry 2+ with negative fluorescence in situ hybridization, or HER2 status unknown.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- At initial diagnosis, thin-section contrast-enhanced computed tomography shows at least one No. 16a2 and/or No. 16b1 lymph node with a short-axis diameter of at least 10 mm and metastatic morphology, such as a round shape, irregular border, central necrosis, clustering, or abnormal enhancement, confirmed by two radiologists or gastric cancer multidisciplinary team physicians with relevant experience.
Key exclusion criteria (9 listed)
- Disease progression, a new distant metastasis, or any suspicious para-aortic lymph node with a short-axis diameter of 10 mm or greater at the post-treatment reassessment.
- Curative-intent R0 resection is not considered feasible, or the participant cannot tolerate both assigned surgical strategies.
- Previous radical gastric cancer surgery or para-aortic operation expected to substantially alter the planned lymphadenectomy, or severe intra-abdominal adhesions or another condition that prevents safe completion of the assigned surgery.
- Uncontrolled active infection, severe cardiac, pulmonary, hepatic, or renal dysfunction, coagulopathy, or another disease that materially increases perioperative risk.
- Preoperative treatment toxicity has not recovered to the allowed level, or an unstable immune-related adverse event requires high-dose systemic immunosuppression.
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 |
|---|---|---|
| Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissectionDistal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and additional systematic dissection of No. 16a2 from the upper border of the celiac trunk to the lower border of the left renal vein and No. 16b1 from the lower border of the left renal vein to the upper border of the inferior mesenteric artery. Robotic, laparoscopic, or open surgery is permitted. | Procedure or surgery | D2 plus PAND |
| Gastrectomy with standard D2 lymphadenectomyDistal, proximal, or total gastrectomy is performed as appropriate for tumor location, with standard D2 lymphadenectomy and without planned systematic No. 16a2 or No. 16b1 dissection. Robotic, laparoscopic, or open surgery is permitted. | Procedure or surgery | D2 alone |
Primary outcome
Progression-free survival rate at 2 years
Time frame: From randomization to 2 years after randomization
Progression-free survival is measured from randomization to the earliest of radiologic or clinical disease progression, postoperative local, regional, or distant recurrence, or death from any cause. Participants without an event are censored at the date of their last adequate disease assessment. The 2-year progression-free survival rate will be estimated by the Kaplan-Meier method.
12 secondary outcomes
Recurrence-free survival rate at 2 years after surgery
Time frame: From surgery to 2 years after surgery
Overall survival
Time frame: From randomization through 5 years after surgery
Cumulative incidence of para-aortic lymph node region recurrence
Time frame: From randomization through 5 years after surgery
R0 resection rate
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Pathological complete response rate
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Number of examined and metastatic regional lymph nodes
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Pathological positivity rate of No. 16 para-aortic lymph nodes in the experimental arm
Time frame: At definitive postoperative pathological assessment, generally within 30 days after surgery
Operative time
Time frame: During the assigned surgery
Estimated intraoperative blood loss
Time frame: During the assigned surgery
Postoperative length of hospital stay
Time frame: From surgery until discharge, generally within 30 days after surgery
Rate of Clavien-Dindo grade III or higher postoperative complications
Time frame: Within 30 days after surgery
All-cause postoperative mortality
Time frame: Within 90 days after surgery
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 3 Nov 2026.
- Individual participant dataSharing planned: No. Due to ethic restriction.
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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.
Hao Xu, MD, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gastrectomy with D2 lymphadenectomy plus para-aortic lymph node dissection and Gastrectomy with standard D2 lymphadenectomy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University 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 13 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hao Xu, MD, PhD (+86-25-68306505, hxu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate at 2 years (time frame: From randomization to 2 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.