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Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

NCT06864481 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-04-27

No results posted yet for this 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.

Conditions

  • Liver Injury
  • Secondary to Immune Checkpoint Inhibitors
  • Cancer Patients

Interventions

OTHER

Blood samples

one Blood sample (20 ml)

Sponsors & Collaborators

  • Association Française pour l'Etude du Foie (AFEF)

    collaborator UNKNOWN

  • University Hospital, Montpellier

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2028-04-22
Completion
2028-04-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864481 on ClinicalTrials.gov