Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy in subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy. The primary purpose is to compare the progression-free survival (PFS) of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy for colorectal cancer, with a planned enrollment of 176 subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy.

NCT Number	NCT05768503
Lead Sponsor	Sun Yat-sen University
Conditions	Metastatic Microsatellite-stable Colorectal Cancer
Enrollment	176 participants
Start Date	2023-03-01
Primary Completion	2026-01 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2023-03-14