NCT06864481

Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Blood samples	one Blood sample (20 ml)

Timeline

• Start date: 2025-04-22
• Primary completion: 2028-04-22
• Completion: 2028-04-22
• First posted: 2025-03-07
• Last updated: 2025-04-27

Locations

1 site across 1 country: France