Tisleizumab Combined With Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors

Exclusion Criteria

• •1. Any active malignancy ≤ 2 years prior to the first dose of study drug, except the specific cancers evaluated in this study and any curatively treated locally recurrent cancer (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
• •2. Participation in other clinical trials within four weeks prior to the first dose of study drug;
• •3. Patients with any evidence or history of bleeding diatheses regardless of severity; patients with any bleeding or bleeding event ≥ CTCAE grade 3 within 4 weeks before the first dose; patients with gastrointestinal diseases such as unhealed wound, fracture, active gastric and duodenal ulcer, ulcerative colitis or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation judged by the investigator;
• •4. Patients with uncontrolled brain metastasis, spinal cord compression, carcinomatous meningitis or brain or leptomeningeal disease found by CT or MRI within 4 weeks before the first dose of study drug;
• •5. Patients with any severe and/or uncontrolled disease, including: a) patients with unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg); b) unstable angina pectoris, myocardial infarction, ≥ grade 2 congestive heart failure, or arrhythmia requiring treatment (including QTc ≥ 480 ms) within 6 months before the first dose of study drug; c) severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy within 14 days before the first dose of study drug, Note: patients with viral hepatitis are allowed to receive antiviral therapy; d) positive HIV test; e) poor control of diabetes (fasting blood glucose ≥ CTCAE grade 2); f) urine routine indicating urine protein ≥ 1 +, and confirmed 24-hour urine protein quantification \> 1.0 g;
• •6. Patients with any active autoimmune disease or a history of autoimmune disease (such as, but not limited: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; patients with asthma requiring medical intervention with bronchodilators can not be included); patients with the following are allowed: vitiligo, psoriasis, alopecia without systemic treatment, well-controlled type I diabetes, hypothyroidism after replacement therapy;
• •8. Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion requiring frequent drainage or medical intervention (clinically significant recurrence,requiring additional intervention within two weeks after intervention, excluding exfoliative cytology of exudates) within 7 days before the first dose of study drug;
• •9. Has any condition that required systemic treatment with corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the first dose of study drug.
• •10. Use of Chinese herbal medicines or Chinese patent medicines with antitumor activity approved by the China National Medical Products Administration (NMPA), regardless of the type of cancer, within 14 days before the first dose of study drug
• •11. Has been administered a live vaccine within 28 days prior to study drug administration
• •12. Has a History of severe hypersensitivity reaction or any contraindication to any component of the tislelizumab or lenvatinib formulation or any component of the container;
• •13. Patients with concomitant diseases that seriously jeopardize the patient's safety or affect the patient's completion of the study judged by the investigator;
• •14. Pregnant and lactating women;
• •15. Malabsorption syndrome or inability to take oral medications for other reasons.