NCT07386158

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Vorolanib
• Clear Cell Renal Cell Carcinoma (ccRCC)
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	Pucotenlimab 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.

Timeline

• Start date: 2025-07-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: China