Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

Inclusion Criteria

• •1\. At least 18 years of age, regardless of gender. 2.Histologically or cytologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of biliary tract, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC) and gallbladder carcinoma (GBC).
• •3.At least one measurable lesion according to RECIST 1.1. 4.Previous first-line standard system chemotherapy failed. First-line standard chemotherapy is defined as gemcitabine combined with capecitabine or platinum.
• •5.Patients with prior local treatment (embolization, chemoembolization, radiofrequency ablation, or radical radiotherapy) must be completed at least 4 weeks before the first administration of the study drug, palliative decompensated radiotherapy (such as bone metastases) must be completed at least 2 weeks before the first administration of the study drug.
• •6.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 7.Life expectancy \>3 months. 8.Adverse reactions must recover to grade 1 or baseline according to CTCAE 5.0 (except for toxicity such as alopecia, grade 2 or less sensory neuropathy, etc., which have been judged no safety risk by investigators).
• •9.Patients should not receive cell growth factors or blood and platelet transfusion within 7 days before the initiate administration of study drug, and laboratory test should meet the following criteria: neutrophile count ≥1.5×10\^9/L;platelet count ≥90×10\^9/L; hemoglobin ≥90 g/L or ≥5.6 mmol/L;serum creatinine ≤1.5×ULN or creatinine clearance rate must be ≥ 50 mL/min when serum creatinine \>1.0×ULN;total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN or ≤2.5×ULN if intrahepatic lesions exist;Albumin ≥3 g/dL.
• •10\. Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR) and prothrombin time (PT) ≤1.5 × ULN for patients not receiving therapeutic anticoagulation.
• •11.Patients with biliary obstruction or no evidence of persistent infection should receive adequate biliary drainage; active or suspected infections are not allowed.
• •12\. Female patients with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the study completion and have a negative serum pregnancy test within 7 days before enrollment, and must be non-lactating. Male patients must agree to use medically approved contraception during the study and for 6 months after the study period.
• •13\. Ability to understand and the willingness to sign a written informed consent.