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

NCT07167251 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Immune Related Adverse Events
  • Immune-Mediated Hepatitis
  • Cancer

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

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Andreas M Schmitt, MD · University Hospital, Basel, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07167251 on ClinicalTrials.gov