Suspended

AK112 and Chemotherapy for Advanced Biliary Tract Cancer

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What is being tested

AK112, Gemcitabine, Cisplatin

+ Durvalumab, Gemcitabine, Cisplatin

Drug
Who is being recruted

Biliary Tract Diseases+3

+ Biliary Tract Neoplasms

+ Digestive System Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorAkeso
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 20, 2024

Actual date on which the first participant was enrolled.

This study is focused on finding the best first-line treatment for patients with advanced biliary tract cancer that cannot be removed through surgery. It involves people who are still able to perform daily activities with little to no limitation, as defined by their performance status. The research aims to compare the effectiveness and safety of a drug called AK112 combined with the chemotherapy drugs gemcitabine and cisplatin, against another drug called durvalumab also combined with gemcitabine and cisplatin. This study is important as it seeks to improve treatment options for individuals suffering from this aggressive form of cancer, potentially offering better survival rates or quality of life. Participants in the study receive one of the two treatment combinations. One group receives the AK112 drug along with gemcitabine and cisplatin, while the other group receives durvalumab with the same chemotherapy drugs. These treatments are given under medical supervision and participants are monitored for their response to the therapy. The study evaluates how well the cancer responds to the treatments, as well as any side effects or safety concerns. The goal is to determine which combination offers the best balance of effectiveness and safety for treating advanced biliary tract cancer.

Official TitleA 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
NCT06591520
Principal SponsorAkeso
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

682 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Biliary Tract DiseasesBiliary Tract NeoplasmsDigestive System DiseasesDigestive System NeoplasmsNeoplasmsNeoplasms by Site

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Harbin Medical University Cancer Hospital

Harbin, ChinaOpen Harbin Medical University Cancer Hospital in Google Maps
Suspended

Zhongshan Hospital, Fudan University

Shanghai, China
Suspended2 Study Centers