Clinical trial NCT06591520: AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
Official title: A Randomized, Controlled, Multi-center Phase III Study of AK112 Combined With Gemcitabine Plus Cisplatin Versus Durvalumab Combined With Gemcitabine Plus Cisplatin as the First-line Treatment for Patients With Advanced Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Biliary Tract Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.


Eligibility criteria: 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 or metastatic 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 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Adverse Events (AEs)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Akeso
name: Wenting Li, MD
role: STUDY_DIRECTOR
References: