NCT06864481 Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis
| NCT ID | NCT06864481 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Liver Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2028-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-04-22 with a primary completion date of 2028-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06864481 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864481 currently recruiting?
Yes, NCT06864481 is actively recruiting participants. Contact the research team at lucy-meunier@chu-montpellier.fr for enrollment information.
Where is the NCT06864481 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT06864481 clinical trial?
NCT06864481 is sponsored by University Hospital, Montpellier. The trial plans to enroll 250 participants.