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Not yet recruiting NCT07627464

Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy

Phase II Interventional Renal Cell Carcinoma (RCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy, Partial nephrectomy.
Who it may be relevant to
Registry conditions: Renal Cell Carcinoma (RCC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • 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.
  • Procedure Partial nephrectomy
    Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.

Primary outcome measures

  • Pentafecta Achievement [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 14 centers
  • Peking University Third Hospital — Beijing
  • Jilin Provincial Cancer Hospital — Changchun
  • Hunan Provincial Cancer Hospital — Changsha
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • Yunnan Provincial Cancer Hospital — Kunming
  • Nanjing Drum Tower Hospital — Nanjing
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • The Affiliated Hospital of Qingdao University — Qingdao
  • … and 6 more centers

Identifiers

NCT: NCT07627464 · ALTER-UC-011 · ALTER-UC-011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗