Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

Recruiting

• Conditions: Liver Injury; Secondary to Immune Checkpoint Inhibitors; Cancer Patients

• Registration Number: NCT06864481
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Study Start: 2025-04-22
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2028-04-22
• Study Completion: 2028-04-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ratio cholestatic phenotype, cytolytic phenotype and mixed phenotype	Day0, Day14, Day30, Day 90, Month 6 and Month 12

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France