NCT06858969

Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for Metastatic Colorectal Cancer

A Phase II Clinical Study of Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX as First-Line Treatment for Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II, open-label, dose-escalation study aims to (1) assess the safety and tolerability of chidamide in combination with PD-1 inhibitor, bevacizumab, and XELOX as first-line therapy for treatment-naïve metastatic colorectal cancer patients, (2) establish the recommended phase II dose (RP2D) of the combination regimen, and (3) obtain preliminary efficacy data including objective response rate (ORR) and progression-free survival (PFS).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Treatment group	Chidamide+XELOX + Bevacizumab+PD-1
DRUG	Standard-of-care control group	XELOX + Bevacizumab+PD-1

Timeline

• Start date: 2025-04-09
• Primary completion: 2026-01-08
• Completion: 2028-01-08
• First posted: 2025-03-05
• Last updated: 2025-03-05