AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer

Inclusion Criteria:

• Be able and willing to provide written informed consent.

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Has a life expectancy of at least 3 months.

• Has a histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC).

• Has no prior systemic anti-tumor therapy for unresectable locally advanced ormetastatic BTC.

• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

• Has adequate organ function.

Exclusion Criteria:

• Has other malignancies within 5 years prior to enrollment.

• Is currently participating in a study of an investigational agent or using aninvestigational device.

• Has known active central nervous system (CNS) metastases.

• Has an active autoimmune disease that has required systemic treatment in the past 2years.

• Has an active infection requiring systemic therapy.

• Has known active Hepatitis B or Hepatitis C.

• History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment.

• Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the study.

• Has received a live virus vaccine within 30 days of the planned first dose of studytherapy.

• Has any concurrent medical condition that, in the opinion of the Investigator, wouldcomplicate or compromise compliance with the study or the well-being of the subject.