Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

NCT06864481 | Recruiting

• 1 other identifier: RECHMPL24_0283
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

Immune checkpoint inhibitors; Immunotherapy; Drug-induced liver injury; Hepatitis; Cholangitis; Ursodeoxycholic acid

Outcome Measures

Primary Outcomes (1)

• Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype

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

Study Arms (1)

Immune Checkpoint Inhibitor-Induced Hepatitis

Observational cohort

Other: Blood samples

Interventions

Blood samples OTHER

one Blood sample (20 ml)

Immune Checkpoint Inhibitor-Induced Hepatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients will be included at the hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Association Française pour l'Etude du Foie (AFEF): collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury; Hepatitis; Cholangitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lucy MEUNIER, M.D

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 7, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2028
• Study Completion (Estimated): April 22, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)