RecruitingPhase 2NCT07386158

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC

Phase II Single-arm Clinical Study of the Efficacy and Safety of Pucotenlimab in Combination With Vorolanib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy


Sponsor

Sun Yat-sen University

Enrollment

21 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pucotenlimab (an immunotherapy) and vorolanib (a targeted therapy that cuts off the blood supply to tumors) — given before surgery in patients with clear cell kidney cancer. The goal is to shrink the tumor enough to allow kidney-sparing surgery in cases where that would otherwise be very difficult. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with clear cell kidney cancer confirmed by biopsy - You are in good health (ECOG score 0–1) and are expected to survive at least 3 months - Your tumor is located in a difficult position or is large enough that kidney-preserving surgery is technically challenging (but still possible) - You are willing to undergo kidney-preserving surgery - Your healthy kidney has reduced function (GFR below 60 mL/min) **You may NOT be eligible if...** - You have received prior treatment for kidney cancer - You have cancer that has spread to lymph nodes or distant organs - You have severe problems with blood counts, liver, or kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPucotenlimab combination with Vorolanib

3.7.1 Vorolanib Vorolanib 200mg PO QD, taken with or without food. 3.7.2 Pucotenlimab Intravenous infusion of 200mg of Pucotenlimab (injection), once every 3 weeks, as one treatment cycle.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Other (Non U.s.), China

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NCT07386158


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