Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer
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.
• The patient had good compliance, could understand the research process of the study, and signed a written informed consent;
• Age ≥18 years, ≤75 years;
• Histologically or cytologically confirmed cholangiocarcinoma;
• Documented metastatic disease;
• At least one measurable lesion according to RECIST v1.1;
• Disease progression after gemcitabine + immunotherapy;
• For patients whose disease recurred after curative resection (R0 or R1), previous adjuvant 5-FU-based chemotherapy is allowed if there is at least 6 month-interval between the last dose of adjuvant chemotherapy and recurrence of disease;
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-1;
• The expected survival time is greater than 3 months;
⁃ Having adequate organ function, as defined below:
∙ Absolute neutrophil count (ANC) ≥1.5\*109/L
‣ Hemoglobin ≥90g/dL
‣ Platelets (PLT) ≥100\*109/L
‣ Total bilirubin \< 1.5 times Upper Normal Value (ULN)
‣ Chemical examination of liver function index (AST\&ALT) \< 2.5 times Upper Limit of Normal (ULN)
‣ Serum creatinine (Cr) ≤1.5×ULN
⁃ Non-pregnant or lactating women; Effective contraception should be used by women/men of childbearing age during the study period and for 6 months after the end of study treatment-