Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ·
Disqualifiers
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.
Trial population
patients will be included at the hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood samples
Other interventionone Blood sample (20 ml)
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Immune Checkpoint Inhibitor-Induced Hepatitis1 intervention
Trial outcomes
Primary outcomes
1
Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype
Time frame
Day0, Day14, Day30, Day 90, Month 6 and Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
Association Française pour l'Etude du Foie (AFEF)
Collaborator
Source ClinicalTrials.gov