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

RecruitingOBSERVATIONAL
Enrollment

63

Participants

Timeline

Start Date

August 25, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Immune Related Adverse EventsImmune-Mediated HepatitisCancer
Interventions
DRUG

Low-dose corticosteroids for immune-related hepatitis grade 3

Prednisolone 0.5-1 mg/kg orally for grade 3 IR-hepatitis; adjusted based on liver function; treatment per local standard of care.

DRUG

Low-dose corticosteroids for immune-related hepatitis grade 2

Hold 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

Trial Locations (2)

4031

RECRUITING

University Hospital Basel, Basel

SW3 6JJ

NOT_YET_RECRUITING

Royal Marsden Hospital, London

All Listed Sponsors
collaborator

Royal Marsden NHS Foundation Trust

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

UMC Utrecht

OTHER

lead

University Hospital, Basel, Switzerland

OTHER