OncoMatch/Clinical Trials/NCT05768503
Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC
Is NCT05768503 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Experimental drug for metastatic microsatellite-stable colorectal cancer.
Treatment: Experimental drug — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: oxaliplatin-containing standard therapy — first-line
Cannot have received: anti-pd-1/pd-l1 antibody
Cannot have received: hdac inhibitor
Cannot have received: irinotecan
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; platelet count ≥ 100×10^9/L; hemoglobin ≥ 9.0 g/dL
Kidney function
serum creatinine (Cr) ≤ 1.5 x ULN; urine protein <2+ or 24-hour urine protein quantification < 1 g
Liver function
serum total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 3.0 × ULN in subjects without liver metastases, and ALT and AST ≤ 5.0 × ULN in subjects with liver metastases; serum albumin ≥ 25 g/L
adequate organ and bone marrow functions with laboratory test values within 7 days prior to enrollment meeting the following requirements...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05768503 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-pd-1/pd-l1 antibody, hdac inhibitor, irinotecan disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages