Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Cancer patients aged 18 years or older
• Treatment with a programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) antibody, or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or a combination of a PD-1 and CTLA-4 antibody, or a PD-1 and lymphocyte-activation gene 3 (LAG-3) antibody
• Occurrence of immune-related hepatitis grade 2 to 3 (as per judgment of the investigator)
• Ability of the patient to comply with the study procedures (management of immune-related hepatitis)
Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
United Kingdom
Royal Marsden Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Andreas M Schmitt, MD
andreasmichael.schmitt@usb.ch
+41 61 265 50 74
Time Frame
Start Date:2025-08-25
Estimated Completion Date:2026-12-31
Participants
Target number of participants:63
Treatments
Immune-related hepatitis grade 2
Grade 2 hepatitis is defined as an elevation of Aspartate transaminase (AST) and/or Alanine aminotransferase (ALT) levels to 3-5 times the upper limit of normal, in accordance with the guidelines of the European Society for Medical Oncology.
Immune-related hepatitis grade 3
Grade 3 hepatitis is defined as an elevation of Aspartate transaminase and/or Alanine aminotransferase levels to 5-20 times the upper limit of normal, in accordance with the guidelines of the European Society for Medical Oncology.