Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Decoding Immunotherapy's liver side effect to keep cancer treatment on track

NCT ID NCT06864481

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at liver inflammation (hepatitis) that can occur in cancer patients treated with immune checkpoint inhibitors, a type of immunotherapy. Researchers aim to describe the different patterns of liver injury and how they respond to treatment. By collecting real-world data from 250 adult patients, the goal is to help doctors make better decisions about managing this side effect and when it might be safe to restart immunotherapy.

What this could mean

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

What this could lead to
If successful, this could lead to better guidelines for managing liver side effects from immunotherapy and safer decisions about restarting cancer treatment.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not apply to all patients or cancer types.

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 250 people

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

Started

Apr 2025

Expected to finish

Apr 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.

Who is studied

patients will be included at the hospital

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 * Patient willing to participate in the study * Patient with cancer receiving neoadjuvant, adjuvant, or maintenance treatment · Patient treated with ICI, either as monotherapy or in combination with another antitumor treatment (targeted therapy, chemotherapy, or radiotherapy), either de novo or after a first-line treatment including ICIs * Patient who has received at least one injection of an ICI · * Onset of hepatitis following treatment initiation, defined by the following criteria: * ALT (alanine aminotransferase) ≥ 5 times the upper normal limit * ALP (alkaline phosphatase) ≥ 2 times the upper normal limit * ALT (alanine aminotransferase) ≥ 3 times the upper normal limit and bilirubin ≥ 2 times the upper normal limit · * Patient with grade 3 or 4 hepatitis, according to the current CTCAE classification * Exclusion criteria: * Patient with another cause of acute hepatitis, including viral, autoimmune, ischemic, acute alcoholic hepatitis, or Wilson's disease. * Patient unable to express their non-opposition to participate in the study. * Person deprived of liberty, under guardianship or curatorship, or in an emergency situation. * Person not affiliated with a social security system or without entitlement to healthcare coverage.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cancer patients are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cancer cholangitis drug-induced hepatitis drug-induced liver injury hepatitis

As listed by the trial registrant

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

Cancer patients Liver injury Secondary to immune checkpoint inhibitors

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

  • Montpellier University Hospital

    RECRUITING

    Montpellier, 34295, France

More trials for these conditions

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