Study of Fruquintinib with PD-1 Antibody and Chidamide for Treating Refractory MSS Metastatic Colorectal Cancer in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment involving fruquintinib, a PD-1 inhibitor called sintilimab, and chidamide for patients with metastatic colorectal cancer that is microsatellite stable MSS and has not responded to standard therapies. This phase 2 clinical trial plans to enroll 46 patients to study whether this combination can improve progression-free survival, along with other measures like overall survival and tumor response. Participants receive fruquintinib orally at 5 mg once daily for 14 days of each 21-day cycle. Sintilimab is given intravenously at 200 mg on the first day of each cycle, with the first infusion lasting 60 minutes and later infusions lasting 30 to 60 minutes. Chidamide is taken orally at 30 mg twice a week, with at least three days between doses. Treatment continues under this schedule and is monitored closely. During the trial, patients will be assessed for tumor size and disease progression, safety, and overall survival. Key tests include imaging according to RECIST v1.1 criteria and regular monitoring of blood counts and organ function. Patients must have measurable cancer lesions and good performance status to participate. The primary outcome is median progression-free survival measured over 24 months, with secondary outcomes including overall survival and response rates.

A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer