A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC

Exclusion Criteria

• •1. Known fibrolamellar HCC; Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
• •2. Known or occurrence of central nervous system (CNS) metastases.
• •3. Ascites with clinical symptoms.
• •4. Known or evidence of GI hemorrhage within the past 6 months.
• •5. Known or occurrence of hemorrhage/ thrombus.
• •6. Known or evidence of abdomen fistula, gastrointestinal perforation, or abdominal abscess within the past 2 months.
• •7. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
• •8. Grade III\~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%.
• •9. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90 mmHg).
• •10. Factors to affect oral administration (such as patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption).
• •11. History of hepatic encephalopathy.
• •12. Known history of human immunodeficiency virus (HIV) infection.
• •13. Active infection or an unexplained fever \> 38.5°C during screening visits.
• •14. Has received a live vaccine within 30 days.
• •15. Prior or planning to organ transplantation including liver transplantation.
• •16. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
• •17. Proteinuria≥ 2+ or 24 hours total urine protein \> 1.0 g.
• •18. Active known, or suspected autoimmune disease.
• •19. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily. prednisone equivalent, are permitted in the absence of active autoimmune disease
• •20. Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.
• •21. Prior therapy with anti-PD-1 or other anti-PD-1/anti-PD-L1 immunotherapy.
• •22. Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.
• •23. Treatment with anti-coagulation therapy(Warfarin or heparin) or anti-platelet therapy(aspirin at dose≥300mg/day, clopidogrel at dose≥75mg/day).
• •24. Pregnant or breast-feeding women.
• •25. According to the investigator, other conditions that may lead to stop the research.