Recruiting

NCT Number: NCT06864481

Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

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.

Recruiting

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Key information

Conditions

Liver Injury Bile Duct Diseases Biliary Tract Diseases Cancer Patients Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Cholangitis Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Hepatitis Liver Diseases Poisoning Secondary to Immune Checkpoint Inhibitors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montpellier University Hospital

Montpellier, 34295, France

Location status: Recruiting

Location contact

Lucy MEUNIER, MD

CONTACT

[email protected]

+33467330224 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Samples

Other

one Blood sample (20 ml)

Primary outcomes

Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype

Time frame: Day0, Day14, Day30, Day 90, Month 6 and Month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Lucy MEUNIER, M.D

CONTACT

[email protected]

Phone: +33467330224

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

French Association for the Study of the Liver

Registry information

Official study title

Description, Course and Treatment of Immune Checkpoint Inhibitor-induced Hepatitis

Acronym: CO-CHILI

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Mar 7, 2025
Registry last updated: Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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