Actively Recruiting
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
Led by University Hospital, Basel, Switzerland · Updated on 2025-09-11
63
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
R
Royal Marsden NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cancer patients aged 18 years or older
- Receiving treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies, including combinations
- Diagnosed with immune-related hepatitis grade 2 or 3
- Able to comply with study procedures for managing immune-related hepatitis
You will not qualify if you...
- Previous immune-related hepatitis requiring systemic therapy
- Already treated with high-dose corticosteroids (>0.5 mg/kg) for immune-related hepatitis
- Immune-related hepatitis with bilirubin >1.5 times upper limit of normal, suspicion of cholangitis, or elevated INR beyond baseline
- Immune-related hepatitis grade 4 at first presentation
- Prior immune-related adverse events treated with systemic immunosuppression
- Concurrent immune-related neurological toxicity or myocarditis requiring high-dose corticosteroids
- Known chronic liver diseases such as autoimmune hepatitis, active hepatitis B, C, or E, hemochromatosis, liver cirrhosis (Child-Pugh B or C), primary biliary cholangitis, or Wilson's disease
- Receiving other cancer treatments besides immune checkpoint inhibitors concurrently
- Condition requiring systemic corticosteroids or immunosuppressive treatment within 14 days before onset of immune-related hepatitis, except stable doses below 10 mg prednisone equivalent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
2
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
Research Team
A
Andreas M Schmitt, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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