Phase II Study of Cryoablation with Anti-PD-1 Antibody Camrelizumab for Advanced Intrahepatic Cholangiocarcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining cryoablation with an anti-PD-1 antibody treatment called Camrelizumab in patients with advanced intrahepatic cholangiocarcinoma who have not responded to first-line systemic therapy. This phase II study is based on evidence that cryoablation may activate immune cells by destroying tumor tissue, while the anti-PD-1 antibody blocks regulatory signals on T cells to enhance immune response against cancer. Participants receive cryoablation treatment starting on day 1. Two weeks later, Camrelizumab is given by intravenous infusion every three weeks at a dose of 3 mgkg. Treatment continues until the disease progresses, unacceptable side effects occur, the participant chooses to stop, or consent is withdrawn. The cryoablation uses a two-cycle freeze-thaw protocol guided by ultrasound or CT imaging to target the tumor. During the study, participants will have regular evaluations including imaging scans like CT or MRI to measure tumor response according to RECIST criteria. Researchers will monitor the objective response rate over up to 24 months, along with secondary measures such as duration of response, progression-free survival, overall survival, disease control rate, and adverse events up to 42 months. Participants will also undergo lab tests and physical assessments to track safety and overall health throughout the study duration.

Cryoablation Combined with Anti-PD-1 Antibody in Patients with Advanced Intrahepatic Cholangiocarcinoma