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RECRUITING
NCT07167251

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

63

Start Date

2025-08-25

Completion Date

2026-12-31

Last Updated

2025-09-11

Healthy Volunteers

No

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

Locations (2)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Royal Marsden Hospital

London, United Kingdom