OncoMatch/Clinical Trials/NCT07253896
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
Is NCT07253896 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Biomarker criteria
Excluded: BRAF mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT07253896 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy, systemic anti-tumor therapy disqualifies patients from enrollment.
Are patients with BRAF alterations eligible?
No. BRAF mutation is an exclusion criterion.
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 qualify