Actively Recruiting
Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis
Led by University Hospital, Montpellier · Updated on 2025-04-27
250
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
A
Association Française pour l'Etude du Foie (AFEF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years or older
- Willingness to participate in the study
- Diagnosed with cancer and receiving neoadjuvant, adjuvant, or maintenance treatment
- Treated with immune checkpoint inhibitors alone or in combination with other anticancer treatments
- Received at least one dose of immune checkpoint inhibitor
- Developed hepatitis after starting treatment, defined by specific elevated liver enzymes (ALT 2 5 times upper normal limit, ALP 2 times upper normal limit, or ALT 2 3 times upper normal limit with bilirubin 2 times upper normal limit)
- Have grade 3 or 4 hepatitis according to CTCAE classification
You will not qualify if you...
- Have another cause of acute hepatitis such as viral, autoimmune, ischemic, alcoholic hepatitis, or Wilson's disease
- Unable to give consent or express non-opposition to participate
- Under guardianship, curatorship, deprived of liberty, or in an emergency situation
- Not affiliated with social security or without healthcare coverage entitlement
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Montpellier University Hospital
Montpellier, France, 34295
Actively Recruiting
Research Team
L
Lucy MEUNIER, M.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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