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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05009953
Study type Interventional
Source CSPC Ouyi Pharmaceutical Co., Ltd.
Contact Xiangdong Cheng, Ph.D
Phone 0086-10-010-87788826
Email Chenxd516@126.com
Status Not yet recruiting
Phase Phase 2
Start date September 2021
Completion date August 2024

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