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Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
Sponsor: University Hospital, Basel, Switzerland
Summary
This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors. It aims to determine whether of 0.5-1miligram per kilogram bodyweight prednisolone is sufficient to manage immune-related hepatitis without the need for dose escalation or additional immunosuppressive therapy.
Official title: Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
63
Start Date
2025-08-25
Completion Date
2026-12-31
Last Updated
2025-09-11
Healthy Volunteers
No
Interventions
Low-dose corticosteroids for immune-related hepatitis grade 3
Prednisolone 0.5-1 mg/kg orally for grade 3 IR-hepatitis; adjusted based on liver function; treatment per local standard of care.
Low-dose corticosteroids for immune-related hepatitis grade 2
Hold immunotherapy and reassess liver function at the treating physician's discretion. If liver function tests persistently worsen or continue to rise, consider administering prednisolone at 0.5 mg/kg body weight
Locations (2)
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Royal Marsden Hospital
London, United Kingdom