Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples.
- Who it may be relevant to
- Registry conditions: Liver Injury, Secondary to Immune Checkpoint Inhibitors, Cancer Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Description, Course and Treatment of Immune Checkpoint Inhibitor-induced Hepatitis
Overview
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.
Interventions
- Other Blood samples
one Blood sample (20 ml)
Primary outcome measures
- Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype [Time frame: Day0, Day14, Day30, Day 90, Month 6 and Month 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Montpellier University Hospital — Montpellier
Identifiers
NCT: NCT06864481 · RECHMPL24_0283