NCT06497985

A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients

A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.

Detailed description

This is a randomised, open-label, multicenter phase III study evaluating the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients. 430 patients will be randomised (1:1) to receive tucidinostat in combination with sintilimab and bevacizumab (experimental arm) or fruquintinib monotherapy (control arm).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Tucidinostat	30mg orally BIW
DRUG	Sintilimab	200 mg intravenously (IV) Q3W
DRUG	Bevacizumab	7.5mg/kg intravenously (IV) Q3W
DRUG	Fruquintinib	5mg orally QD

Timeline

• Start date: 2024-12-06
• Primary completion: 2028-05-31
• Completion: 2028-09-30
• First posted: 2024-07-12
• Last updated: 2026-03-19

Locations

1 site across 1 country: China