Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Low-dose corticosteroids for immune-related hepatitis grade 3
- Low-dose corticosteroids for immune-related hepatitis grade 2
Treatment groups
63 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Basel, Switzerland
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
Odense University Hospital
Collaborator
UMC Utrecht
Collaborator
Source ClinicalTrials.gov