Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

Last updated: April 23, 2025
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Treatment

Blood samples

Clinical Study ID

NCT06864481
RECHMPL24_0283
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anotherantitumor treatment (targeted therapy, chemotherapy, or radiotherapy), eitherde 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 followingcriteria:

  • 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 andbilirubin ≥ 2 times the upper normal limit ·

  • Patient with grade 3 or 4 hepatitis, according to the current CTCAEclassification

Exclusion

  • 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 emergencysituation.

  • Person not affiliated with a social security system or without entitlement tohealthcare coverage.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Blood samples
Phase:
Study Start date:
April 22, 2025
Estimated Completion Date:
April 22, 2028

Connect with a study center

  • Montpellier University Hospital

    Montpellier, 34295
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.