Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy
ALTER-UC-011
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
1 other identifier
interventional
144
1 country
14
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2026
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2026
CompletedStudy Start
First participant enrolled
May 31, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
June 4, 2026
May 1, 2026
2.6 years
May 20, 2026
May 31, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Through study completion, an average of 1 year
Secondary Outcomes (4)
Primary tumor partial response (PR) rate in the experimental arm
Through study completion, an average of 1 year
Safety
Through study completion, an average of 2 years
2-year DFS Rate
2-years
R.E.N.A.L. score changes in the experimental group
Through study completion, an average of 1 year
Study Arms (2)
Anlotinib + Benmelstobart
EXPERIMENTALAnlotinib 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 COMPARATORPatients receive upfront partial nephrectomy
Interventions
Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma.
Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Peking University Third Hospital
Beijing, China
Jilin Provincial Cancer Hospital
Changchun, China
Hunan Provincial Cancer Hospital
Changsha, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Yunnan Provincial Cancer Hospital
Kunming, China
Nanjing Drum Tower Hospital
Nanjing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Liaoning Provincial Cancer Hospital
Shenyang, China
Shanxi Province Cancer Hospital
Taiyuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2026
First Posted
June 4, 2026
Study Start
May 31, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
June 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share