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New hope for bile duct cancer: targeted combo targets hard-to-treat gene mutation

NCT ID NCT07282262

Disease control Sponsor: Peking Union Medical College Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a precision medicine approach for people with advanced biliary tract cancer that has a specific IDH1 gene mutation and has stopped responding to standard chemotherapy. About 300 participants will receive a combination of ivosidenib (a targeted pill) plus either lenvatinib or an immunotherapy drug. The goal is to see if this combination can shrink tumors or slow cancer growth.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

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

Started

May 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 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 * Voluntary Participation: Signed informed consent. * Genetic Mutation: Presence of an IDH1 mutation confirmed by genetic testing. * Disease Status： * Newly diagnosed, untreated advanced/metastatic disease; OR * Recurrence \>6 months after curative-intent surgery (with or without adjuvant therapy). * Measurable Disease: At least one measurable lesion per RECIST 1.1. * Performance Status: ECOG performance status of 0 or 1. * Life Expectancy： ≥3 months. * Organ Function: Adequate hematological, hepatic, and renal function. * Contraception: Use of highly effective contraception for women of childbearing potential and men. Exclusion Criteria * Prior Treatment: Previous treatment with Ivosidenib. * Cancer Type: Ampulla of Vater cancer. * Pregnancy： Pregnant or breastfeeding women. * Allergy: Known hypersensitivity to any component of the study drugs. * Recent Therapy: Local anti-tumor therapy or major surgery within 4 weeks prior to initiation. * Medical Conditions: * Uncontrolled hypertension. * Significant cardiovascular disease. * Active or untreated CNS metastases. * Active autoimmune disease. * Uncontrolled active infection (e.g., HBV, HCV, HIV). * Significant bleeding tendency or history. * Severe non-healing wounds. * History of organ transplantation. * Concurrent Participation: Participation in another interventional clinical trial.

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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

How to take part

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

  1. The places running it

    1 site. 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

  • Beijing Peking Union Medical College Hospital Outpatient Department

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.