Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids

Recruiting now

Conditions studied: Immune Related Adverse Events, Immune-Mediated Hepatitis, Cancer

In brief

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.

Key facts

Study ID

NCT07167251

Run by

University Hospital, Basel, Switzerland

People needed

63

Starts

2025-08-25

Expected to finish

2026-12-31

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University Hospital Basel — Basel, Canton of Basel-City, Switzerland (enrolling)
• Royal Marsden Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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