Observing liver injury caused by immune checkpoint inhibitors in cancer patients
Description, Course and Treatment of Immune Checkpoint Inhibitor-induced Hepatitis
This study looks at how certain cancer treatments affect the liver in patients to better understand the types of liver injuries and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06864481 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult cancer patients aged 18 and older who have experienced significant liver injury after receiving immune checkpoint inhibitors.
Not a fit: Patients with liver injury due to causes other than immune checkpoint inhibitors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for liver injuries in cancer patients treated with immune checkpoint inhibitors.
How similar studies have performed: While there is limited consensus on managing CHILI, this study builds on existing knowledge and aims to fill gaps in understanding, suggesting a novel approach to a recognized issue.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier
- Montpellier University Hospital — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Lucy MEUNIER, M.D
- Email: lucy-meunier@chu-montpellier.fr
- Phone: Phone: +33467330224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.