HAIC With Oxaliplatin, 5-FU and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC

Inclusion criteria

• Biliary tract cancer proved by histology or cytology
• Metastatic advanced or locally advanced unresectable biliary tract cancer, including gallbladder cancer, intrahepatic cholangiocarcinoma and perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.
• At least one measurable lesion within liver;
• No prior intra-arterial/systemic chemotherapy or other systemic therapies
• Prior resection, TACE or ablation will be allowed.
• Age from 18 years old to 80 years old.
• the performance of Eastern Cooperative Oncology Group (ECOG) <2
• Child-Pugh A or Child-Pugh B (≤ score 7).
• Expectant survival time ≥ 3 months.
• Baseline blood count test and blood biochemical must meet following criteria:

• Hemoglobin ≥ 90 g/L;
• Absolute neutrophil count ≥ 1.5×10^9/L;
• Blood platelet count ≥ 100×10^9/L;
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal (ULN);
• Total bilirubin ≤ 2 times of ULN;
• Serum creatinine ≤ 1.5 times of ULN;
• Albumin ≥ 30 g/L.
• Patients sign informed consent.

Exclusion criteria

• Distal cholangiocarcinoma.
• Allergic to contrast agent.
• Pregnant or lactational.
• Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
• More than 80 years old.
• Previous systematic chemotherapy or radiotherapy.
• Child-Pugh C or Child-Pugh B (≥ score 8).
• Coinstantaneous a lot of malignant hydrothorax or ascites.
• History of organ transplantation (including bone marrow auto-transplantation and peripheral stem cell transplantation).
• Coinstantaneous infection and need anti-infection therapy.
• Hepatitis B virus DNA load ≥ 100 IU/ml (patients whose hepatitis B virus DNA load decreased to < 100 IU/ml after anti-virus therapy could be enrolled).
• Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
• Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
• Without legal capacity.
• Impact the study because of medical or ethical reasons.
• Uncorrectable coagulation disorder.
• Obvious abnormal in ECG or obvious clinical symptoms of heart disease, like congestive heart failure (CHF), coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension.
• History of myocardial infarction within 12 months, or Grade III/IV of heart function.
• Severe liver disease (like cirrhosis), renal disease, respiratory disease, unmanageable diabetes or other kinds of systematic disease.