NCT05831891

Fruquintinib and SeRplulimab: Opening New Frontiers in Treating Non-clear Cell Renal Cell Carcinoma

A Single-arm, Multicenter, Prospective Clinical Study of Efficacy and Safety of Fruquintinib Combined With Serplulimab in First-line Treatment of Non-clear Renal Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is design to prospectively investigate the safety and efficacy of Fruquintinib combined with Serplulimab in first-line treatment of non-clear renal cell carcinoma. Fruquintinib, a vascular endothelial growth factor receptor inhibitor, is an anticancer drug independently developed in China to treat refractory metastatic colorectal cancer (mCRC). This is a Single-arm, multicenter, prospective phase 2 clinical study.

Detailed description

The study is ongoing. This is a single-arm, multicenter clinical study enrolling 39 patients with metastatic or unresectable nccRCC at Renji Hospital and Zhongshan Hospital in Shanghai, China. The study is divided into a safety-run-in stage and a cohort expansion stage. Six patients were enrolled in the safety-run-in stage, and no dose-limited toxicity or treatment-related deaths occurred within the 28-day observation period. Consequently, the cohort was expanded to 39 patients. The treatment includes Fruquintinib 5mg, qd, 2w on/1w off, combined with Serplulimab 4.5mg/kg, IV drip, d1, q3w. Tumor response is evaluated at baseline, every 6 weeks during treatment, and at end-of-treatment visit.

Conditions

• Non-clear Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Fruquintinib combined with Serplulimab	Fruquintinib 5mg, qd, 2w on/1w off and Serplulimab 4.5mg/kg, IV drip, d1, q3w

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-06-30
• Completion: 2026-07-31
• First posted: 2023-04-26
• Last updated: 2024-12-19

Locations

1 site across 1 country: China