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โ† Trials
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Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Montpellier
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In plain words

What the trial is, and whether it could suit you

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 internatio

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Age โ‰ฅ 18 years * Patient willing to participate in the study * Patient with cancer receiving neoadjuvant, adjuvant, or maintenance treatment ยท 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 ยท * Onset of hepatitis following treatment initiation, defined by the following criteria: * ALT (alanine aminotransferase) โ‰ฅ 5 times the upper normal limit * ALP (alkaline phosphatase) โ‰ฅ 2 times the upper normal limit * ALT (alanine aminotransferase) โ‰ฅ 3 times the upper normal limit and bilirubin โ‰ฅ 2 times the upper normal limit ยท * 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.
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What it tests

  • Blood samples
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Where

1 site
Montpellier University Hospital
Montpellier, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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