Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids (NCT07167251) | Clinical Trial Compass
RecruitingNot Applicable
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
Switzerland, United Kingdom63 participantsStarted 2025-08-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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)
✕. 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)
What they're measuring
1
Proportion of patients with resolution of their IR hepatitis CTCAE grade 3 within 8 weeks of onset