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

Korábbi kezelés

• Has other malignancies within 5 years prior to enrollment.
• Is currently participating in a study of an investigational agent or using an investigational device.
• History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment.
• Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
• Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.

Más betegség

• Has an active autoimmune disease that has required systemic treatment in the past 2 years.
• Has an active infection requiring systemic therapy.
• Has known active Hepatitis B or Hepatitis C.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Egyéb

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

• 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 or metastatic BTC.
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Has adequate organ function.