Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy (ALTER-UC-011)

May 31, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital
        • Contact:
          • Shudong Zhang
      • Changchun, China
        • Jilin Provincial Cancer Hospital
        • Contact:
          • Changdong Zhou
      • Changsha, China
        • Hunan Provincial Cancer Hospital
        • Contact:
          • Xie Yu
      • Hangzhou, China
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Dan Xia
      • Kunming, China
        • Yunnan Provincial Cancer Hospital
        • Contact:
          • Yong Yang
      • Nanjing, China
        • Nanjing Drum Tower Hospital
        • Contact:
          • Hongqian Guo
      • Nanning, China
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Jiwen Chen
      • Qingdao, China
        • The affiliated hospital of Qingdao university
        • Contact:
          • Ke Wang
      • Shanghai, China
        • Huadong Hospital Affiliated to Fudan University
        • Contact:
      • Shenyang, China
        • Liaoning Provincial Cancer Hospital
        • Contact:
          • Bing Hu
      • Taiyuan, China
        • Shanxi Province Cancer Hospital
        • Contact:
          • Xuebing Han
      • Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
      • Wuhan, China
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Xiaoping Zhang
      • Zhengzhou, China
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Xuepei Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged between 18 and 75 years, inclusive.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.
  4. Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  5. No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.

Exclusion Criteria:

  1. Subjects with a solitary kidney tumor.
  2. Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).
  3. Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau [VHL] disease).
  4. Subjects with a prior history of renal transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib + Benmelstobart
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
Drug: Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy
Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma.
Active Comparator: Upfront partial nephrectomy (standard care)
Patients receive upfront partial nephrectomy
Procedure: Partial nephrectomy
Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary tumor partial response (PR) rate in the experimental arm
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Safety
Time Frame: Through study completion, an average of 2 years
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
Through study completion, an average of 2 years
2-year DFS Rate
Time Frame: 2-years
2-year Disease-Free Survival Rate
2-years
R.E.N.A.L. score changes in the experimental group
Time Frame: Through study completion, an average of 1 year

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)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTER-UC-011 (Other Identifier: Same as current)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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