Status:
NOT_YET_RECRUITING
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
Lead Sponsor:
Akeso
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The pu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Has other malignancies within 5 years prior to enrollment.
- Is currently participating in a study of an investigational agent or using an investigational device.
- Has known active central nervous system (CNS) metastases.
- 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.
- 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 with cooperation with the requirements of the study.
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
682 Patients enrolled
Trial Details
Trial ID
NCT06591520
Start Date
October 1 2024
End Date
December 1 2027
Last Update
September 19 2024
Active Locations (2)
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1
Harbin Medical University Cancer Hospital
Harbin, China
2
Zhongshan Hospital, Fudan University
Shanghai, China