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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06566755 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS mutation is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression testing required is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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 qualifyRelated pages