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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib+Sintilimab+Chidamide	Fruquintinib: 5 mg orally once daily on days 1-14 of each 21-day cycle (Q3W). Sintilimab (anti-PD-1): 200 mg intravenously on day 1 of each cycle (first infusion over 60 minutes, subsequent infusions over 30-60 minutes, Q3W). Chidamide: 30 mg orally twice weekly (BIW; e.g., Monday \& Thursday or Tuesday \& Friday, with ≥3 days between doses), taken 30 minutes after meals.

Timeline

• Start date: 2025-01-22
• Primary completion: 2026-07-22
• Completion: 2027-01-22
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

1 site across 1 country: China