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NCT Number: NCT06591520

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Harbin Medical University Cancer Hospital, Harbin, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AK112, Gemcitabine, Cisplatin

Drug

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.

Durvalumab, Gemcitabine, Cisplatin

Drug

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 outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 2 years

    OS is the time from randomization to death due to any cause.

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Up to approximately 2 years

    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.

  2. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.

  3. Duration of Response (DoR)

    Time frame: Up to approximately 2 years

    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.

  4. Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years

    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.

  5. Time to response (TTR)

    Time frame: Up to approximately 2 years

    TTR is defined as the time to response based on RECIST v1.1.

  6. Adverse Events (AEs)

    Time frame: Up to approximately 2 years

    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.

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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