Phase 2 Trial of Cryoablation with Lenvatinib and QL1706 IparomlimabTuvonralimab for Advanced Intrahepatic Cholangiocarcinoma After Prior Treatments

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining cryoablation with lenvatinib plus QL1706 a bispecific antibody targeting PD-1 and CTLA-4 in patients with advanced intrahepatic cholangiocarcinoma ICC who have not responded to first-line treatments. The study is a phase 2 trial involving two groups of patients who have progressed after different prior therapies, including GemCis plus PD-1PD-L1 inhibitors and other targeted treatments. Participants will receive cryoablation using a two-cycle freeze-thaw protocol, with imaging to monitor the treated area. One to three days after cryoablation, they will begin treatment with lenvatinib taken orally daily dose based on body weight and QL1706 given intravenously every 21 days. Both groups receive the same combination treatment following their respective prior therapy failures. During the study, participants will undergo regular assessments including CT or MRI scans to measure tumor response, evaluations of side effects, and blood tests to monitor organ function. Researchers will track how well tumors respond, the duration and timing of responses, disease control, progression-free survival, and overall survival for up to 42 months. Safety and treatment-related adverse events will also be closely monitored throughout the study period.

Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma