Clin2
NCT05345847Possibly a fitRecruiting

Steroid-sparing treatment for immune hepatitis during cancer immunotherapy

Hepatitis Immune

Part of Digestive system, Immune system & allergy clinical trials.

This trial studies a way to treat inflammation of the liver (hepatitis) caused by immune cancer medicines (anti-PD-1/PD-L1, sometimes with anti-CTLA-4) without relying on high-dose steroids. It may help reduce steroid side effects while keeping liver inflammation under control.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
56 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • Be at least 18 years old and able to sign consent
  • Have cancer being treated with anti–PD-1 or anti–PD-L1 medicines (with or without anti–CTLA-4)
  • Develop immune-related hepatitis with liver inflammation that is grade 2 or grade 3, and start the trial within 10 days of that diagnosis
  • Your liver injury must be judged likely caused by the immunotherapy (RUCAM score 6 or higher)
  • You should not have other known liver diseases (like hepatitis B/C or autoimmune liver conditions) or certain other liver injury causes
  • You should not need ongoing immune-suppressing medicines or corticosteroids for reasons other than limited exceptions (like certain skin/inhaled uses)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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