OncoMatch/Clinical Trials/NCT06566755
Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
Is NCT06566755 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Cadonilimab (AK104) combined with chemotherapy and bevacizumab for colorectal cancer.
Treatment: Cadonilimab (AK104) combined with chemotherapy and bevacizumab — The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS mutation
Genetic testing revealed RAS (including KRAS and NRAS) mutations
Required: NRAS mutation
Genetic testing revealed RAS (including KRAS and NRAS) mutations
Required: PD-L1 (CD274) expression testing required (testing required; no eligibility threshold specified)
Agree to provide archived or freshly obtained tumor tissue samples ... to confirm PD-L1 expression
Disease stage
Required: Stage IV (UICC/AJCC colorectal TNM stage System (8th edition 2017))
Metastatic disease required
Recurrent or incurable metastatic colorectal adenocarcinoma confirmed by Histopathology.(UICC/AJCC colorectal TNM stage System (8th edition 2017))
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1 inhibitor
Previously received treatment with PD-1 monoclonal antibody
Cannot have received: PD-L1 inhibitor
Previously received treatment with ... PD-L1 monoclonal antibody
Cannot have received: CTLA-4 inhibitor
Previously received treatment with ... CTLA-4 monoclonal antibody
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9.0g/dL
Kidney function
Creatinine <1.5 × ULN, or creatinine clearance rate (CrCl) calculated value ≥ 50mL/min; Urinary protein <2+ or 24-hour urine protein quantification <1.0g
Liver function
Serum total bilirubin (TBiL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (AST and ALT ≤ 5 for subjects with liver metastasis) × ULN, but not accompanied by elevated bilirubin
Cardiac function
Left ventricular ejection fraction (LVEF) <50% [excluded]; Uncontrolled hypertension (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after standard antihypertensive therapy) [excluded]
Having good organ function: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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