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IMFINZI combo passes Real-World safety check in bile duct cancer

NCT ID NCT05835778

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracked side effects in 236 people with advanced biliary tract cancer who received IMFINZI (durvalumab) together with standard chemotherapy (gemcitabine and cisplatin). The goal was to see how often adverse reactions happen in everyday medical practice, outside of a controlled trial. All participants had cancer that could not be removed by surgery.

What this could mean

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

Active substance
durvalumab (IMFINZI) plus gemcitabine and cisplatin
What this could lead to
If the results confirm safety, this combination could become a standard option for people with advanced biliary tract cancer.
What could go wrong
This is a completed observational safety study, not a test of whether the treatment works. Side effects are still possible, and the study did not compare against a placebo or other treatment.

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.

Participants

236 people

The number who actually took part.

Started

Jun 2023

Finished

Nov 2025

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.

Who is studied

Patients with curatively unresectable biliary tract cancer

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients with curatively unresectable biliary tract cancer who receive IMFINZI for the first time in combination with gemcitabine hydrochloride and cisplatin. Exclusion Criteria: \-

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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

  • Research Site

    Aichi, Japan

  • Research Site

    Aomori, Japan

  • Research Site

    Chiba, Japan

  • Research Site

    Ehime, Japan

  • Research Site

    Fukushima, Japan

  • Research Site

    Hokkaido, Japan

  • Research Site

    Hyōgo, Japan

  • Research Site

    Kagawa, Japan

  • Research Site

    Kanagawa, Japan

  • Research Site

    Kyoto, Japan

  • Research Site

    Miyagi, Japan

  • Research Site

    Nagano, Japan

  • Research Site

    Nagasaki, Japan

  • Research Site

    Nara, Japan

  • Research Site

    Numakunai, Japan

  • Research Site

    Okayama, Japan

  • Research Site

    Osaka, Japan

  • Research Site

    Saitama, Japan

  • Research Site

    Shiga, Japan

  • Research Site

    Shimane, Japan

  • Research Site

    Shizuoka, Japan

  • Research Site

    Tochigi, Japan

  • Research Site

    Tokyo, Japan

  • Research Site

    Yamaguchi, Japan

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