OncoMatch/Clinical Trials/NCT07253896
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
Is NCT07253896 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies AK104 and cetuximab or bevacizumab and FOLFIRI for safety.
Treatment: AK104 and cetuximab or bevacizumab and FOLFIRI — Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Excluded: BRAF mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (oxaliplatin) — first-line
Previously only received first-line systemic anti-tumor therapy based on oxaliplatin (FOLFOX or CAPOX)
Cannot have received: immunotherapy
Have received any immunotherapy against tumors in the past, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumors
Cannot have received: systemic anti-tumor therapy
Exception: other than first-line oxaliplatin-based therapy
other systemic anti-tumor treatments for metastatic colorectal cancer are not allowed
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (1500/mm3); platelets ≥ 100 × 10^9/L (100000/mm3); hemoglobin ≥ 90 g/L; no use of blood components or growth factors within 7 days prior to treatment
Kidney function
Creatinine clearance rate (CrCl) ≥ 50 mL/min (Cockcroft-Gault formula); urinary protein ≤ 1+ or 24-hour urinary protein quantification <1.0 g
Liver function
Total serum bilirubin (TBil) ≤ 1.5 × ULN; for liver metastasis or Gilbert disease, TBil ≤ 3 × ULN; AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN with liver metastasis); serum albumin ≥ 28 g/L
Determine good organ function through the following requirements: Hematology... Kidney... Liver... Coagulation function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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