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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06282120
Status
Unknown

Conditions

  • Metastatic Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are: * To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer * To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer.

Key Dates

Start date
Jan 1, 2024
Status verified
Feb 2024
Primary completion
Jan 5, 2025
Completion
Jan 1, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Study Arms
    Drug: Irinotecan Hydrochloride Liposome Injection 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.

Primary Outcome Measure

Progression Free Survival [ Time Frame: from the date of enrollment to the earlier of the date of confirmed progression or death from any cause. (assessed up to 12 months ]

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