Clinical Research Directory

Inclusion Criteria: * Age 18-75 years old. * Patients with histologically confirmed, resectable biliary malignancies with R0 resection. * Postoperative pathology indicated the following risk factors: positive lymph nodes, vascular invasion, nerve invasion and so on. * Has not received systemic chemotherapy before. * The ECOG score is 0 to 1. * Bone marrow and organ function were good: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5× upper limit of normal range (ULN), ≤5×ULN with liver metastasis; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 mL/min (calculated according to Cockroft-Gault). * Expected survival ≥3 months. * Volunteer to participate in the study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent. Exclusion Criteria: * Patients allergic to the investigational drug and its excipients. * Known or suspected central nervous system or lymphatic metastasis. * Cannot discontinue use or has not discontinued use of CYP3A, CYP2C8, and UGT1A1 potent depressants or inducers (e.g., anticonvulsants \[phenytoin, phenobarbital, or carbamazepine\] within 2 weeks prior to enrollment), rifampicin, rifambutin, St.John's Wort, Grapefruit juice, clarithromycin, Itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, Indinavir, etc.). * There are signs and symptoms of intestinal obstruction. * Other malignancies within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancers. * Autoimmune disease or long-term steroid use. * Patients who are pregnant or nursing women, and patients who refuse to receive contraception during their reproductive age. * Patients deemed unsuitable for participation in this study. * Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, etc.