RecruitingNot Applicable

Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

France250 participantsStarted 2025-04-22

Plain-language summary

Background and Study Rationale Immune checkpoint inhibitors (ICI) are a breakthrough cancer treatment that boosts the immune system to fight tumors. While effective, they can cause immune-related side effects, including liver inflammation (ICI-induced hepatitis or CHILI), which affects up to 25% of patients. Severe cases requiring treatment discontinuation are rare but challenging to manage. Study Objective This multicenter prospective study aims to better understand CHILI, its clinical patterns, treatment response, and risk of recurrence. It will focus on different types of liver injury (cholestatic, hepatocellular, or mixed) to guide better treatment decisions. Innovation and Approach Currently, there is no clear consensus on how to manage CHILI or when to safely restart immunotherapy. This study will collect real-world data from adult patients treated with ICIs, following international guidelines or a pragmatic approach when no consensus exists. Findings will help improve care strategies for patients experiencing ICI-related liver toxicity.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is observational and is tracking liver injury that happens as a side effect of immune checkpoint inhibitor treatment I'm already receiving or considering, would joining this cohort change anything about how I'm actually treated, or would it just mean my data is being collected and studied?
2This trial is measuring different patterns of liver injury — cholestatic, cytolytic, and mixed — so would my doctor be looking more closely at my liver function tests while I'm on immune checkpoint inhibitors, and what symptoms should I watch for that might signal one of these patterns?
3Since this is a prospective cohort study rather than a treatment trial, what does participating actually involve for me in terms of extra visits, blood draws, or liver monitoring beyond what I'd already be doing as part of my cancer care?
4Given that immune checkpoint inhibitor-induced liver injury is a known risk with these treatments, how does my doctor currently plan to monitor and manage that risk, and would being in this study give me access to any additional expertise or oversight in that area?
5Are there any aspects of my specific cancer type or the particular immune checkpoint inhibitor I might receive that would make liver-related side effects more or less likely for me, and is that something this study's findings might eventually help answer?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype

Timeframe: Day0, Day14, Day30, Day 90, Month 6 and Month 12

Trial details

NCT IDNCT06864481

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-04-22

Contact for this trial

Lucy MEUNIER, M.D

Phone: +33467330224 lucy-meunier@chu-montpellier.fr

View on ClinicalTrials.gov More Liver Injury trials