This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus QL1706 (iparomlimab/tuvonralimab) in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.
Written informed consent obtained.
Age ≥ 18 years at time of study entry.
Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma
Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity. Cohort A must have progressed after GemCis plus PD1/PD-L1 inhibitor. Cohort B must have progressed after GemCis plus PD1/PD-L1 inhibitor and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors.
History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
Prior treatment with cryoablation.
RFA and resection administered less than 4 weeks prior to study treatment start.