AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer
Ivonescimab (AK112) Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer: a Randomized, Controlled, Multicenter Phase II Study
Sponsor: Sun Yat-sen University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
PFS
Time frame: up to 24 months
Secondary Endpoints
ORR
DCR
DoR
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign written informed consent 2. Agree to provide tumor and blood samples for biomarker detection 3. Age ≥18 and ≤75 years at enrollment, regardless of gender 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 5. Expected survival ≥3 months 6. Pathologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma 7. Confirmed MSS/pMMR-type CRC by immunohistochemistry (IHC), PCR, or NGS 8. Intolerance to oxaliplatin-containing standard first-line therapy, disease progression, or recurrence within \< 6 months after oxaliplatin adjuvant therapy 9. Adequate organ function (last 14 days without intervention): 1. Absolute neutrophil count (ANC) ≥1.5×10⁹/L without granulocyte colony-stimulating factor1. 2. Platelets ≥100×10⁹/L without transfusion1. 3. Hemoglobin \>9 g/dL without transfusion or erythropoietin1. 4. Total bilirubin ≤1.5×ULN1. 5. AST/ALT ≤2.5×ULN1. 6. Serum creatinine ≤1.5×…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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