Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

NCT ID: NCT06864481

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2028-04-22

Brief 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.

Conditions

Liver Injury; Secondary to Immune Checkpoint Inhibitors; Cancer Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Immune Checkpoint Inhibitor-Induced Hepatitis

Observational cohort

Blood samples

Intervention Type: OTHER

one Blood sample (20 ml)

Interventions

Blood samples

one Blood sample (20 ml)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association Française pour l'Etude du Foie (AFEF)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montpellier University Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lucy MEUNIER, M.D

Role: CONTACT

lucy-meunier@chu-montpellier.fr

Phone: +33467330224

Facility Contacts

Lucy MEUNIER, MD

Role: primary

lucy-meunier@chu-montpellier.fr

+33467330224 ext. +33

Other Identifiers

RECHMPL24_0283

Identifier Type: -

Identifier Source: org_study_id