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New targeted pill shows promise for rare bile duct cancer in Real-World study

NCT ID NCT06607302

Disease control Sponsor: iOMEDICO AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study is tracking 100 adults with a rare and aggressive bile duct cancer that has a specific IDH1 gene mutation. Participants will take the targeted drug ivosidenib, which was recently approved in Europe. Researchers will monitor how long the cancer stays under control, overall survival, and quality of life in everyday medical practice.

What this could mean

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

Active substance
ivosidenib (a targeted cancer pill)
What this could lead to
If successful, this study could confirm that ivosidenib is a safe and effective treatment option for people with this rare bile duct cancer, potentially improving survival and quality of life.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The cancer is aggressive, and the drug may not work for everyone or may cause side effects.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

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.

Who is studied

Patients with IDH1 R132-mutated locally advanced or metastatic CCC who have received at least one prior line of systemic therapy and who have already been scheduled by their treating physician to receive ivosidenib prior to enrolment in IDHIRA are eligible to participate.

Ages

18 years and older

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: * Age 18 years or older. * Histologically confirmed locally advanced or metastatic CCC with a documented IDH1 R132 mutation diagnosed by an appropriate diagnostic test * Patients must have at least one prior systemic therapy * Decision for treatment with ivosidenib according to current SmPC. * Signed written informed consent before or within 6 weeks of first ivosidenib dose (inclusion of patients up to 6 weeks after first ivosidenib intake is allowed for patients not participating in the PRO module) * For patients participating in the PRO module (optional): * Dated signature of informed consent form before start of study treatment. * Willingness and capability to participate in PRO assessment in German language. * Other criteria according to current SmPC. Exclusion Criteria: * Participation in an interventional clinical trial within 30 days prior to enrolment or concurrent participation in an interventional clinical trial except for the follow-up period. * Other contraindications according to current SmPC.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma

As listed by the trial registrant

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

Cholangiocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Caritas Krankenhaus Bad Mergentheim

    RECRUITING

    Bad Mergentheim, Germany

  • DRK Kliniken Berlin, Klinik für Innere Medizin

    RECRUITING

    Berlin, Germany

  • Gemeinschaftspraxis Hämatologie - Onkologie

    RECRUITING

    Dresden, Germany

  • Gemeinschaftspraxis für Internistische Onkologie und Hämatologie

    RECRUITING

    Rheine, Germany

  • Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerda

    RECRUITING

    Bad Liebenwerda, Germany

  • Medizinisches Versorgungszentrum Mönchengladbach

    RECRUITING

    Mönchengladbach, Germany

  • Onkologie Hannover

    RECRUITING

    Hanover, Germany

  • Onkologie Hof

    RECRUITING

    Hof, Germany

  • Onkologisches Versorgungszentrum Berlin MVZ

    RECRUITING

    Berlin, Germany

  • Onkologisches Zentrum Passau

    RECRUITING

    Passau, Germany

  • Onkozentrum Dresden

    RECRUITING

    Dresden, Germany

  • RoMed Klinikum Rosenheim, Hämatologie und Onkologie

    RECRUITING

    Rosenheim, Germany

  • TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Innere Medizin II

    RECRUITING

    München, Germany

  • Universitätsklinikum Augsburg, II. Medizinische Klinik

    RECRUITING

    Augsburg, Germany

  • Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

    RECRUITING

    Essen, Germany

  • ze:roPRAXEN MVZ für Innere Medizin

    RECRUITING

    Weinheim, Germany

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