Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a side effect that some cancer patients experience when they are treated with immune checkpoint inhibitors (ICIs), which are medications that help the immune system fight cancer. Specifically, the study is focused on liver inflammation caused by these treatments, known as immune checkpoint inhibitor-induced hepatitis (CHILI). The goal is to better understand how this liver injury happens, how patients respond to treatment, and if it can come back after treatment. This is important because while many patients benefit from ICIs, up to 25% may develop liver problems that can complicate their cancer care.

To participate in the trial, volunteers must be adults aged 18 or older who are currently receiving treatment for cancer with ICIs. They should have experienced liver inflammation that meets specific medical criteria after starting their ICI treatment. Participants will be closely monitored to gather valuable information that could help improve care for future patients facing similar challenges. It's important to note that the trial is not yet recruiting participants, so there's still time to learn more if you or someone you know might be interested.

Gender

ALL

Eligibility criteria

• 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 another antitumor treatment (targeted therapy, chemotherapy, or radiotherapy), either de 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 following criteria:
• • 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 and bilirubin ≥ 2 times the upper normal limit ·
• • Patient with grade 3 or 4 hepatitis, according to the current CTCAE classification
• * 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 emergency situation.
• • Person not affiliated with a social security system or without entitlement to healthcare coverage.