Efficacy of Cadonilimab (AK104) Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS Colorectal Cancer With Liver Metastases: A Prospective, Randomized Controlled, Single-Center Phase II Clinical Trial (APSOC)
This is a prospective, randomized controlled, single-center phase II clinical study. It aims to compare the efficacy of AK104 plus radiotherapy combined with standard therapy versus standard therapy as first-line treatment for liver metastases from metastatic colorectal cancer.
• Age ≥ 18 years, with no gender restriction;
• Histologically or cytologically confirmed colorectal cancer;
• Presence of liver metastases, with at least one measurable target lesion (per RECIST 1.1 criteria) in addition to a single liver metastatic lesion amenable to radiotherapy; patients with initially resectable colorectal cancer liver metastases are excluded;
• Treatment-naive patients; or patients with postoperative recurrence who have not received any anti-tumor therapy within 6 months and at least 6 months have elapsed since the last adjuvant chemotherapy;
• ECOG performance status score of 0-1;
• Expected overall survival ≥ 3 months;
• Adequate organ function and reserve, meeting the following laboratory criteria within 7 days prior to screening (inclusive):
• HB ≥ 90 g/dL, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L; BIL \< 1.5 × ULN, ALT and AST \< 2.5 × ULN; ALT and AST \< 5 × ULN in the presence of liver metastases; Serum Cr ≤ 1 × ULN, creatinine clearance \> 50 mL/min (calculated using the Cockcroft-Gault formula); International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients on anticoagulant therapy, PT within the intended therapeutic range is acceptable;
• Voluntary participation in the study, provision of signed informed consent, good compliance, and willingness to comply with follow-up procedures.