drugset / Trial / NCT06979908

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

NCT06979908

Phase 2 Recruiting 46 enrolled The First Hospital of Jilin University
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-arm, open-label, single-center clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with a PD-1 inhibitor and chidamide in patients with refractory MSS-type metastatic colorectal cancer (mCRC). A total of 46 patients are planned to be enrolled, with the primary endpoint being median progression-free survival (mPFS). Secondary endpoints include median overall survival (mOS), objective response rate (ORR), and safety.

Timeline

Start
2025-01-22
Primary completion
2026-07-22
Completion
2027-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Fruquintinib Small molecule 5 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject Tucidinostat Small molecule 30 mg Oral

Indications