Intrahepatic Cholangiocarcinoma Clinical Trial
Official title:
An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer.
This is an open-label, parallel, multicentre, phase II study to evaluate the efficacy and safety of irinotecan liposome injection. Eligible patients will be divided into two cohorts according to the criteria for the corresponding cohort. The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV). The patients in cohort 2 will receive irinotecan liposome injection combined with a PD-1 inhibitor, 5-Fluorouracil and Leucovorin. ;
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