Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With BTC

Prior treatment

• Patients who had received radiotherapy or chemotherapy previously
• Incomplete surgery recovery or biliary obstruction exist
• Patients with prior or concurrent malignancy(excluded Cured basal cell carcinoma of the skin and Carcinoma in situ elsewhere)
• There are significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
• Patients are receiving immunosuppressant and continue using within 2 weeks before enrollment
• Abnormal coagulation(have tendency to bleed or receiving thrombolytic or anticoagulant therapy)
• Patients had abdominal fistula, gastrointestinal perforation, or abdominal abscess less than 4 weeks before first dose.
• Patients past or present with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc
• Patients are participating in other relevant clinical studies or it has been less than 1 month since the end of the previous clinical study; Patients maybe receive other systemic antitumor therapy during the study period;
• Patients received live vaccination less than 4 weeks before administration or possibly receive during the study period.

Other illness

• Patients are allergy to macromolecular protein preparation(including anti-PD-1 antibody, uracil, cytosine pharmaceutical ingredients)
• Patients had any active autoimmune disease or had experience of autoimmune disease.
• Patients with disease of the heart that are not well controlled
• Patients had active infection or unexplained fever during screening and before first dose
• Patients have congenital or acquired immune deficiency; Hepatitis B patients: HBV DNA≥10\^3/ml, Hepatitis C patients: HCV RNA≥10\^3/ml, Chronic hepatitis B virus carriers: HBV DNA\<2000 IU/ml（\<10\^4 copies/ml), patients must receive antiviral therapy during the trial
• Patients had history of psychotropic substance abuse, alcohol abuse, or drug abuse.

Other

• Patients with pancreatic/ampullary carcinoma
• Patients with mucous gallbladder carcinoma
• Patients with radiographs confirmed distant metastases
• Patients with ascites or pleural effusion requiring therapeutic puncture or drainage
• Patients cannot or does not agree to pay the cost of examination and treatment expense
• The researchers concluded the patients should be excluded from this study

• Ages 18 and above
• Pathological reported showed Biliary tract cancer (include intrahepatic cholangiocarcinoma (IHCC), extrahepatic/hilar cholangiocarcinoma, muscle infiltrated gallbladder carcinoma or distal cholangiocarcinoma)，patients received R0 resection(including liver resection, pancreatectomy, or both).
• ECOG PS 0-1
• Patients can tolerate the combination therapy and survive longer than 6 months.
• Organ function(Exclude use blood components and cell growth factors for 14 days): Neutrophils (ANC) ≥1,500/mm3, Platelet count (PLT)≥100,000/mm3, Hemoglobin (Hb) ≥9g/dL; Serum creatinine(SCR) ≤1.5\*upper limit of normal(ULN),or creatinine clearance rate≥50 ml/min(Cockcroft-Gault Formula),Total bilirubin(TBIL)≤ 2\*ULN,Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3\*ULN, urine protein≤2+(if urine protein≥2+, 24-hour urinary protein quantity must ≤1g), Adequate surgical biliary drainage and no infection signal.
• The coagulation function was normal (without active bleeding and thrombotic disease): International normalized ratio(INR)≤1.5\*ULN, activated partial thromboplastin time(APTT)≤1.5×ULN, prothrombin time(PT)≤1.5\*ULN.
• Women without surgical sterilization or childbearing age who are required to use a medically approved contraceptive method (such as an intrauterine device, birth control pill or condom) during the study period and for 3 months after the study period; Women are of reproductive age and not undergoing surgical sterilization whose the serum or urine HCG test must be negative within 7 days prior to study enrollment and must be non lactation period. Male patients without surgical sterilization or reproductive age are required to consent with their spouse to use a medically approved contraceptive method during the study treatment period and for 3 months after the study treatment period.
• The patients are voluntarily enrolled in the study, with good compliance and coordinate the follow-up for safety and survival