Actively Recruiting
Description, Course and Treatment of Immune Checkpoint Inhibitor-induced Hepatitis
Led by University Hospital, Montpellier · Updated on 2025-04-27
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
A
Association Française pour l'Etude du Foie (AFEF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Immune checkpoint inhibitors (ICIs) are a breakthrough treatment for cancer that help the immune system fight tumors. However, they can cause immune-related side effects such as liver inflammation, known as ICI-induced hepatitis or CHILI, affecting up to 25% of patients. This study aims to better understand CHILI, including its clinical patterns, how patients respond to treatment, and the risk of the liver injury returning. It focuses on different types of liver injury to support improved treatment decisions for patients. The study is observational and will collect real-world data from adult cancer patients who have received at least one ICI injection as part of their treatment, either alone or combined with other therapies like chemotherapy or radiotherapy. Researchers will follow patients with liver injury after ICI treatment, classified by liver enzyme levels and severity grade. Blood samples will be taken to monitor liver injury types and progression at multiple time points, including Day 0, Day 14, Day 30, Day 90, Month 6, and Month 12. Participants will be monitored over time with regular assessments of liver injury patterns using blood tests. The main outcome measured is the ratio of different liver injury types at scheduled visits up to one year. The study will help guide treatment strategies by observing how liver injury evolves and responds to care. Participation involves providing blood samples and medical data while following the course of liver inflammation related to immune therapy.
CONDITIONS
Brief Title
Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing to participate in the study
- Diagnosed with cancer and receiving neoadjuvant, adjuvant, or maintenance treatment
- Treated with immune checkpoint inhibitors alone or combined with other cancer therapies
- Received at least one injection of an immune checkpoint inhibitor
- Developed hepatitis after starting treatment, defined by elevated liver enzymes (ALT or ALP) and bilirubin levels
- Have grade 3 or 4 hepatitis according to current CTCAE classification
You will not qualify if you...
- Having another cause of acute hepatitis such as viral, autoimmune, ischemic, alcoholic hepatitis, or Wilson's disease
- Unable to provide consent to participate
- Under guardianship, deprived of liberty, or in an emergency situation
- Not affiliated with a social security system or lacking healthcare coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants are observed with blood samples taken to evaluate the course and treatment of immune checkpoint inhibitor-induced hepatitis.
6 visits for blood sample collection at Day 0, Day 14, Day 30, Day 90, Month 6, and Month 12
Trial Site Locations
Total: 1 location
1
Montpellier University Hospital
Montpellier, France, 34295
Actively Recruiting
Research Team
L
Lucy MEUNIER, M.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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