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.
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.