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New drug combo aims to fight bile duct cancer

NCT ID NCT06591520

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial is testing whether a new immunotherapy drug called AK112, when combined with standard chemotherapy, works better than another immunotherapy (durvalumab) plus the same chemo for people with advanced bile duct cancer. The study includes 682 participants who have not had prior treatment for their advanced cancer. Researchers are measuring how long patients live and how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AK112 (an experimental immunotherapy drug) combined with gemcitabine and cisplatin chemotherapy
What this could lead to
If successful, this could offer a new first-line treatment option for advanced biliary tract cancer, potentially improving survival compared to current standard therapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The experimental drug may not prove more effective than the existing treatment, and side effects from the combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

682 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer

Contacts and locations

Locations

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Zhongshan Hospital, Fudan University

    Shanghai, China

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