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
This trial does not accept healthy volunteersQualifiers
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 population
The target patient population of this study are patients treated with immune checkpoint inhibitors (either as monotherapy with an anti-programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) antibody, or with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or as combination therapy with an PD-1 and CTLA-4 antibody, or an PD-1 and lymphocyte-activation gene 3 (LAG3) antibody) who develop grade 2 or 3 Immune-related hepatitis independently of the treated cancer entity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Low-dose corticosteroids for immune-related hepatitis grade 3
DrugPrednisolone 0.5-1 mg/kg orally for grade 3 IR-hepatitis; adjusted based on liver function; treatment per local standard of care.
Low-dose corticosteroids for immune-related hepatitis grade 2
DrugHold immunotherapy and reassess liver function at the treating physician's discretion. If liver function tests persistently worsen or continue to rise, consider administering prednisolone at 0.5 mg/kg body weight
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: Immune-related hepatitis grade 21 intervention
Group B: Immune-related hepatitis grade 31 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with resolution of their IR hepatitis CTCAE grade 3 within 8 weeks of onset
Resoultion is defined as back to baseline or grade 1 without escalation of the corticosteroid dose, without additional immunosuppression and with discontinuation of corticosteroids or reduction to a maximum of 10 mg of Prednisolone
Time frame
8 weeks of onsetSecondary outcomes
1
Proportion of patients with resolution of their IR hepatitis CTCAE grade 2 or 3 within 8 weeks of onset
Resoultion is defined as back to baseline or grade 1 without escalation of the corticosteroid dose, without additional immunosuppression and with discontinuation of corticosteroids or reduction to a maximum of 10 mg of Prednisolone
Time frame
8 weeks2
Proportion of patients requiring dose escalation of corticosteroids
Time frame
Outcome assessed at each visit until end of follow-up (6 months).3
Time to resolution of IR hepatitis
Time frame
Outcome assessed at each visit until end of follow-up (6 months).4
Peak dose of corticosteroids
Maximum dose of corticosteroids used for the treatment of IR hepatitis
Time frame
Outcome assessed at each visit until end of follow-up (6 months).Other outcomes
1
Recruitment rate
Number of registered patients per months
Time frame
At recruitment completion (last patient enrolled, up to 18 months)2
Retention rate
The number and proportion of patients with a complete follow-up
Time frame
At study completion (final follow-up, 6 months after inclusion of the last patient])Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
Odense University Hospital
Collaborator
UMC Utrecht
Collaborator
Source ClinicalTrials.gov