Status:
RECRUITING
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Royal Marsden NHS Foundation Trust
Odense University Hospital
Conditions:
Immune Related Adverse Events
Immune-Mediated Hepatitis
Eligibility:
All Genders
18+ years
Brief 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 whe...
Detailed Description
Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy but are associated with immune-related adverse events (irAEs), including immune-related hepatitis, a potentially serious complica...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Previous Immune-related hepatitis that required systemic therapy
- Treatment for Immune-related hepatitis has already been initiated with high-dose corticosteroids (\>0.5 mg/kg body weight)
- Immune-related hepatitis with bilirubin \> 1.5 ULN or clinical suspicion of cholangitis or elevated INR (beyond baseline)
- Immune-related hepatitis with grade 4 at first presentation
- Prior irAE treated with systemic immunosuppression
- Simultaneous immune-related neurological toxicity or immune-related myocarditis (since these usually have to be treated with high doses of corticosteroids)
- a. Patients with other immune-related adverse events may be included according to the investigator's judgment
- Known liver disease (e.g., autoimmune hepatitis, active hepatitis B, C or E, hemochromatosis, liver cirrhosis Child-Pugh Score B or C, primary biliary cholangitis, primary biliary cirrhosis, Morbus Wilson)
- a. Patients with liver metastasis are eligible
- Patients receiving cancer treatment other than immune checkpoint inhibitors in parallel (e.g., tyrosine kinase inhibitors or chemotherapy).
- a. Patients who have received other cancer treatments in previous cycles are eligible, provided the treating physician does not assume any toxicity from the other medication.
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to occurrence of IR hepatitis. Stable corticosteroid doses of \< 10mg prednisone equivalent are allowed.
Key Trial Info
Start Date :
August 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT07167251
Start Date
August 25 2025
End Date
December 31 2026
Last Update
September 11 2025
Active Locations (2)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031
2
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ