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Could a common liver drug replace steroids for immunotherapy side effects?

NCT ID NCT07378761

Disease control Sponsor: University Hospital, Montpellier 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether ursodeoxycholic acid (UDCA), a drug already used for other liver conditions, can treat cholestatic hepatitis—a liver inflammation caused by immunotherapy—better than standard steroids. About 94 adults with cancer (excluding liver cancer) who develop this side effect will be randomly assigned to UDCA or steroids. The main goal is to see if liver function improves by at least 25% after 21 days.

What this could mean

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

Active substance
Ursodeoxycholic acid (UDCA)
What this could lead to
If UDCA works, it could offer a safer, effective alternative to steroids for treating liver side effects from immunotherapy, helping patients stay on their cancer treatment.
What could go wrong
This is a small, early-phase trial (94 people) that hasn't started yet. UDCA may not work as well as steroids, and some patients may still need steroids.

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 94 people

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

Started

Jun 2026

Expected to finish

Dec 2028

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 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: * Adults ≥18 years old * Any type of cancer except hepatocellular or cholangiocarcinoma * At least one ICI injection * Cholestatic hepatitis Grade CTC-AE 3 or 4 Exclusion Criteria: * Ongoing corticosteroids treatment * Other causes of hepatitis * Cirrhosis * ICI for hepatocellular carcinoma or cholangiocarcinoma * Biliary obstruction * Medical contraindication to corticosteroids or UDCA * Mixed or hepatocellular hepatitis * Total bilirubin \> 1,5 ULN, Prothrombin rate \< 70% * Medical contraindication to MRI or liver biopsy * Oher serious side effects requiring corticosteroids * Pregnant and breast-feeding patients * Patients under articles L1121-5 to 8 of the public health code * Lack of informed consent * Patients not affiliated with French social security system * Patients uncapable of understanding french

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Conditions

The condition(s) this trial relates to.

autoimmune cholangitis neoplasm primary biliary cholangitis

As listed by the trial registrant

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

Immune-mediated cholestasis

How to take part

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

  1. The places running it

    6 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

  • APHP Paul Brousse

    NOT_YET_RECRUITING

    Paris, France

  • CHU Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, France

  • CHU Montpellier

    RECRUITING

    Montpellier, France

  • CHU Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • CHU Toulouse

    NOT_YET_RECRUITING

    Toulouse, France

  • HCL Croix Rousse

    RECRUITING

    Lyon, France