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 (May 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
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 no protein deletion
immunohistochemistry for DNA mismatch repair (MMR) proteins, including MLH1, MSH2, MSH6 and PMS2 protein expression, which result in no protein deletion
Required: MSH2 no protein deletion
immunohistochemistry for DNA mismatch repair (MMR) proteins, including MLH1, MSH2, MSH6 and PMS2 protein expression, which result in no protein deletion
Required: MSH6 no protein deletion
immunohistochemistry for DNA mismatch repair (MMR) proteins, including MLH1, MSH2, MSH6 and PMS2 protein expression, which result in no protein deletion
Required: PMS2 no protein deletion
immunohistochemistry for DNA mismatch repair (MMR) proteins, including MLH1, MSH2, MSH6 and PMS2 protein expression, which result in no protein deletion
Disease stage
Metastatic disease required
Locally advanced unresectable or metastatic colorectal adenocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: oxaliplatin-containing chemotherapy (oxaliplatin) — first-line
Patients who have failed first-line oxaliplatin-containing standard therapy and have imaging evidence (e.g., CT scan) or clinical evidence (e.g., cytology report of new ascites or pleural effusion) of disease progression during or after treatment; patients whose intolerance of toxicity has led to discontinuation of first-line oxaliplatin-containing standard therapy may be enrolled; relapse within 180 days after the last dose of oxaliplatin-containing adjuvant therapy.
Cannot have received: anti-PD-1 therapy
Prior exposure to any anti-PD-1 antibody
Cannot have received: anti-PD-L1 therapy
Prior exposure to any anti-PD-L1 antibody
Cannot have received: HDAC inhibitor
Prior exposure to any...HDAC inhibitor
Cannot have received: topoisomerase inhibitor (irinotecan)
Prior exposure to...irinotecan
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥ 1.5×10^9/L; platelet count (PLT) ≥ 100×10^9/L; hemoglobin level (HGB) ≥ 9.0 g/dL
Kidney function
serum creatinine (Cr) ≤ 1.5 x ULN; urine protein <2+ or, if ≥2+, 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
Subjects having 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.
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