Phase II Study of Cryoablation with Sintilimab and Regorafenib for Previously Treated Colorectal Cancer Liver Metastases CASTLE-03

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining cryoablation with the drugs Sintilimab and regorafenib in patients who have colorectal cancer that has spread to the liver and have already undergone at least two previous chemotherapy treatments. This phase II study explores how this combination might improve treatment outcomes by activating immune cells and blocking certain pathways that help cancer cells survive. Participants will receive cryoablation, a procedure that uses freezing to destroy tumor tissue, guided by ultrasound or CT imaging. Two weeks after cryoablation, patients will start Sintilimab given intravenously every three weeks and daily oral regorafenib taken in 21-day cycles followed by a 7-day break. Treatment will continue until disease progression, unacceptable side effects, or withdrawal. This study is sponsored by Fudan University and is designed to monitor the combined treatment approach for up to 42 months. During the study, participants will have regular scans such as spiral CT or MRI to measure tumor response according to established criteria. Researchers will track the objective response rate over 24 months as the primary outcome and also evaluate duration of response, progression-free survival, overall survival, disease control rate, and adverse events. Blood tests and other lab work will assess organ function and safety. Participants are expected to follow the treatment plan, attend scheduled visits, and complete required evaluations for the study duration.

Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis