Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

January 5, 2025

Study Completion Date

January 1, 2026

Conditions
Metastatic Biliary Tract Cancer
Interventions
DRUG

Irinotecan Hydrochloride Liposome Injection ;Fluorouracil ;Leucovorin;immunotherapy

The recommended dose and regimen of Irinotecan Hydrochloride Liposome Injection is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 3 weeks.It can be combined or partially combined immunotherapy.

Trial Locations (1)

300000

RECRUITING

Tianjin Cancer Hospital Airport Hospital, Tianjin

Sponsors
All Listed Sponsors
collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

lead

Tianjin Medical University Cancer Institute and Hospital

OTHER