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Clinical Trial NCT06591520 for Biliary Tract Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer Phase 3 682

Active, not recruiting
Clinical Trial NCT06591520 is designed to study Treatment for Biliary Tract Cancer. It is a Phase 3 interventional study that is active, not recruiting, having started on October 20, 2024, with plans to enroll 682 participants. Led by Akeso, it is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on January 21, 2026.
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.
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

Conditions
Biliary Tract Cancer
Other Study IDs
  • AK112-309
NCT ID Number
NCT06591520
Start Date (Actual)
2024-10-20
Last Update Posted
2026-01-21
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
682
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAK112 + Gemcitabine + Cisplatin
AK112, Gemcitabine, Cisplatin
AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.
Active ComparatorDurvalumab + Gemcitabine + Cisplatin
Durvalumab, Gemcitabine, Cisplatin
Durvalumab will be administered at 1500mg intravenously (IV) every three weeks (Q3W) for 8 cycles and followed by monotherapy every 4 weeks. Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Up to approximately 2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.
Up to approximately 2 years
Objective Response Rate (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Up to approximately 2 years
Duration of Response (DoR)
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression.
Up to approximately 2 years
Disease Control Rate (DCR)
DCR is the proportion of subjects with complete response(CR) , partial response (PR) or stable disease (SD) , assessed by investigators based on RECIST v1.1.
Up to approximately 2 years
Time to response (TTR)
TTR is defined as the time to response based on RECIST v1.1.
Up to approximately 2 years
Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Up to approximately 2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
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2 Study Locations in 1 Countries
Harbin Medical University Cancer Hospital, Harbin, China
Zhongshan Hospital, Fudan University, Shanghai, China