Observing liver injury caused by immune checkpoint inhibitors in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to understand immune checkpoint inhibitor-induced hepatitis (CHILI) in cancer patients receiving immunotherapy. It will collect real-world data on the clinical patterns, treatment responses, and recurrence risks associated with liver injuries caused by these therapies. The study will focus on different types of liver injury, including cholestatic, hepatocellular, or mixed, to inform better treatment decisions. By following international guidelines and pragmatic approaches, the study seeks to improve patient care and management of CHILI.

Why it matters

Who can join: the full rules

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.

Where it's running

• Montpellier University Hospital
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Lucy MEUNIER, M.D
• Email: lucy-meunier@chu-montpellier.fr
• Phone: Phone: +33467330224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.