This study will evaluate the efficacy and safety of Oncolytic virus H101 combined with lenvatinib plus Toripalimab compared with FOLFOX in patients with advanced biliary tract cancer (BTC) 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 biliary tract cancer.
Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.
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 oncolytic virus.
Prior treatment with Lenvatinib or other targeted therapy.