Renal Cell Carcinoma (RCC)Phase 2ALTER-UC-011NCT07627464
Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy
A Phase 2 study testing Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy and Partial nephrectomy in people with Renal Cell Carcinoma (RCC), run by Tianjin Medical University Cancer Institute and Hospital at 14 sites in China.
Trial summary
Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy and Partial nephrectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 14 sitesChina
- Study dates
- 31 May 2026to 31 Dec 2029
- 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
- Aged between 18 and 75 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.
- Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.
Who cannot join
- Subjects with a solitary kidney tumor.
- Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).
- Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau [VHL] disease).
- Subjects with a prior history of renal transplantation.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites
Peking University Third Hospital
Beijing
Shudong Zhang
Jilin Provincial Cancer Hospital
Changchun
Changdong Zhou
Hunan Provincial Cancer Hospital
Changsha
Xie Yu
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Dan Xia
Yunnan Provincial Cancer Hospital
Kunming
Yong Yang
Nanjing Drum Tower Hospital
Nanjing
Hongqian Guo
The First Affiliated Hospital of Guangxi Medical University
Nanning
Jiwen Chen
The Affiliated Hospital of Qingdao University
Qingdao
Ke Wang
Huadong Hospital Affiliated to Fudan University
Shanghai
Hailiang Zhang, +86135 2407 1783, zhanghl918@163.com
Liaoning Provincial Cancer Hospital
Shenyang
Bing Hu
Shanxi Province Cancer Hospital
Taiyuan
Xuebing Han
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Yao Xin, Ph.D., +86-02223340123, yaoxin@tjmuch.com
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Xiaoping Zhang
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Xuepei Zhang
About this study
Official title: A Multicenter, Randomized Controlled Phase II Study of Neoadjuvant Anlotinib Hydrochloride Capsules Combined With Benmelstobart Injection Versus Surgery Alone for Localized Renal Cell Carcinoma Planned for Partial Nephrectomy
Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy, Partial nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochloride + Benmelstobart + Partial nephrectomyDrug
Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma.
Partial nephrectomyProcedure or surgery
Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib + Benmelstobart | Experimental | Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)； Benmelstobart 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle Receives: Drug: Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy |
| Upfront partial nephrectomy (standard care) | Active comparator | Patients receive upfront partial nephrectomy Receives: Procedure: Partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pentafecta Achievement
It includes: negative surgical margin, warm ischemia time (WIT) ≤ 25 minutes, no perioperative complications, estimated glomerular filtration rate (eGFR) preservation ≥ 90% at 9-12 months postoperatively, and no increase in chronic kidney disease (CKD) stage at 9-12 months postoperatively.
The eGFR preservation rate is calculated as the percentage of the postoperative eGFR relative to the preoperative baseline eGFR.
An increase in CKD stage is defined as progression to Stage III, IV, or V; progression from Stage I to Stage II is not considered an increase in CKD stage.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Primary tumor partial response (PR) rate in the experimental arm
Measured: Through study completion, an average of 1 year
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE 6.0 To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants
Measured: Through study completion, an average of 2 years
2-year DFS Rate
2-year Disease-Free Survival Rate
Measured: 2-years
R.E.N.A.L. score changes in the experimental group
The R.E.N.A.L. Nephrometry Score is a 4-12 point anatomical classification system for renal tumors, with each letter representing a key feature scored as 1, 2, or 3 points, as follows:
(R) Radius (Maximum tumor diameter, cm)； (E) Exophytic/endophytic properties (Tumor growth pattern)； (N) Nearness to the collecting system or renal sinus (Tumor distance to collecting system/renal sinus, mm)； (A) Anterior/posterior location； (L) Location relative to the polar line (Relationship to renal polar line; suffix (h) is added if the tumor is adjacent to major renal artery or vein)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627464
- Sponsor's protocol ID
- ALTER-UC-011
- Other IDs
- ALTER-UC-011
- Acronym
- ALTER-UC-011
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Phase II Study of Neoadjuvant Anlotinib Hydrochloride Capsules Combined With Benmelstobart Injection Versus Surgery Alone for Localized Renal Cell Carcinoma Planned for Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT07627464
- Acronym / sponsor ID
- ALTER-UC-011 / ALTER-UC-011
- Conditions
- Renal Cell Carcinoma (RCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jun 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.
Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib + Benmelstobart | Experimental | Drug: Anlotinib hydrochloride + Benmelstobart + Partial nephrectomyAnlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)； Benmelstobart 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle |
| Upfront partial nephrectomy (standard care) | Active comparator | Procedure: Partial nephrectomyPatients receive upfront partial nephrectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 75 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.
- Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.
Key exclusion criteria (4 listed)
- Subjects with a solitary kidney tumor.
- Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).
- Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau [VHL] disease).
- Subjects with a prior history of renal transplantation.
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 |
|---|---|---|
| Anlotinib hydrochloride + Benmelstobart + Partial nephrectomyPatients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma. | Drug | Anlotinib + Benmelstobart |
| Partial nephrectomyPatients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma. | Procedure or surgery | Upfront partial nephrectomy (standard care) |
Primary outcome
Pentafecta Achievement
Time frame: Through study completion, an average of 1 year
It includes: negative surgical margin, warm ischemia time (WIT) ≤ 25 minutes, no perioperative complications, estimated glomerular filtration rate (eGFR) preservation ≥ 90% at 9-12 months postoperatively, and no increase in chronic kidney disease (CKD) stage at 9-12 months postoperatively. The eGFR preservation rate is calculated as the percentage of the postoperative eGFR relative to the preoperative baseline eGFR. An increase in CKD stage is defined as progression to Stage III, IV, or V; progression from Stage I to Stage II is not considered an increase in CKD stage.
4 secondary outcomes
Primary tumor partial response (PR) rate in the experimental arm
Time frame: Through study completion, an average of 1 year
Safety
Time frame: Through study completion, an average of 2 years
2-year DFS Rate
Time frame: 2-years
R.E.N.A.L. score changes in the experimental group
Time frame: Through study completion, an average of 1 year
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 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy and Partial nephrectomy in people with Renal Cell Carcinoma (RCC), run by Tianjin Medical University Cancer Institute and Hospital at 14 sites 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 5 inclusion and 4 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 4 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 14 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pentafecta Achievement (time frame: Through study completion, an average of 1 year). 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 4 Jun 2026.