RecruitingPhase 2

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC

China21 participantsStarted 2025-07-10

Plain-language 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)

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Voluntarily sign a written informed consent form (ICF).
✓. Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
✓. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.
✓. Expected survival period ≥ 3 months.
✓. Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma
✓. ECOG score 0 or 1
✓. The patient is willing to undergo kidney preservation surgery
✓. Preoperative assessment of healthy kidney GFR\<60 ml/min through renal dynamic imaging

What they're measuring

Objective Response Rate (ORR) based on RECIST 1.1 criteria.

Timeframe: Evaluation at the end of Cycle 2 or Cycle 4 (each cycle is 21 days) of Pucotenlimab treatment

Trial details

NCT IDNCT07386158

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Zhiling Zhang, M.D

+862087342318 zhangzhl@sysucc.org.cn

View on ClinicalTrials.gov More Vorolanib trials