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New combo therapy shows promise for bile duct cancer

NCT ID NCT05771480

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 3 times

Summary

This phase 3 trial is testing whether adding the immunotherapy drug durvalumab to standard chemotherapy can help people with advanced biliary tract cancer (a type of bile duct cancer). About 142 participants will receive the combination, and researchers will track side effects, survival, and tumor shrinkage. The goal is to find a more effective first-line treatment for this hard-to-treat cancer.

What this could mean

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

Active substance
durvalumab (an immunotherapy drug) combined with gemcitabine-based chemotherapy
What this could lead to
If successful, this combination could become a new standard first-line treatment, helping people with advanced biliary tract cancer live longer and control their disease better.
What could go wrong
This is a single-arm, open-label study without a placebo group, so results may be less definitive. Side effects like severe immune reactions or infections are possible.

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

142 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Sep 2026

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 130 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: * Histologically confirmed, unresectable advanced or metastatic biliary tract carcinoma (BTC) including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma, and ampulla of Vater (AoV) carcinoma * Participants with unresectable or metastatic BTC * A World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0 to 2 * At least one lesion that qualifies as a Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) target lesion at baseline * Adequate organ and bone marrow function * Body weight of \> 30 kg * Negative pregnancy test (serum) for women of childbearing potential * Female participants must be one year post-menopausal (amenorrhoeic for 12 months without an alternative medical cause) * Male and female participants and their partners must be surgically sterile or on their chosen method of birth control as per the protocol. Exclusion Criteria: * Any evidence of diseases such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations, history of uncontrolled or symptomatic cardiac disease, and history of allogenic organ transplant * Active or prior documented autoimmune or inflammatory disorders * History of another primary malignancy, except for malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study intervention * History of leptomeningeal carcinomatosis * History of active primary immunodeficiency * Known to have tested positive for human immunodeficiency virus \[HIV\] (positive HIV 1/2 antibodies) or active tuberculosis infection * Participants co-infected with Hepatitis B virus (HBV) and Hepatitis C virus (HCV) or co-infected with HBV and Hepatitis D virus (HDV) * Persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade \> 1) caused by previous anticancer therapy * Central nervous system metastases requiring treatment or history of spinal cord compression * Known allergy or hypersensitivity to any of the study intervention or any of the study intervention excipients. * Any concurrent chemotherapy, other than the one allowed in the study, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment * Palliative radiotherapy with a limited field of radiation within 2 weeks of the first dose of study intervention, or radiotherapy with a wide field of radiation or radiotherapy affecting more than 30% of the bone marrow within 4 weeks before the first dose of study intervention * Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention * Major surgical procedure within 28 days prior to the first dose of IMP * Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines * Receipt of the last dose of anticancer therapy within 28 days prior to the first dose of IMP

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms carcinoma of the ampulla of vater cholangiocarcinoma gallbladder carcinoma

As listed by the trial registrant

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

Biliary tract cancer

Contacts and locations

Locations

  • Research Site

    Mobile, Alabama, 36607, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    Portland, Oregon, 97213, United States

  • Research Site

    Clichy, 92110, France

  • Research Site

    Dijon, 21079, France

  • Research Site

    Montpellier, 34090, France

  • Research Site

    Villejuif, 94800, France

  • Research Site

    Chemnitz, 09131, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Castelfranco Veneto, 31033, Italy

  • Research Site

    Foggia, 71122, Italy

  • Research Site

    Palermo, 90146, Italy

  • Research Site

    Pisa, 56126, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Kyoto, 606-8507, Japan

  • Research Site

    Osaka, 541-8567, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Ube, 755-8505, Japan

  • Research Site

    Wakayama, 641-8509, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Singapore, 169610, Singapore

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Madrid, 28027, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Seville, 41013, Spain

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