Skip to content
Back to search

NCT07167251Recruiting

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

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.

Inclusion criteria

1. Cancer patients aged 18 years or older 2. 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 3. Occurrence of immune-related hepatitis grade 2 to 3 (as per judgment of the investigator) 4. Ability of the patient to comply with the study procedures (management of immune-related hepatitis)

Exclusion criteria

1. Previous Immune-related hepatitis that required systemic therapy 2. Treatment for Immune-related hepatitis has already been initiated with high-dose corticosteroids (\>0.5 mg/kg body weight) 3. Immune-related hepatitis with bilirubin \> 1.5 ULN or clinical suspicion of cholangitis or elevated INR (beyond baseline) 4. Immune-related hepatitis with grade 4 at first presentation 5. Prior irAE treated with systemic immunosuppression 6. Simultaneous immune-related neurological toxicity or immune-related myocarditis (since these usually have to be treated with high doses of corticosteroids) a. Patients with other immune-related adverse events may be included according to the investigator's judgment 7. Known liver disease (e.g., autoimmune hepatitis, active hepatitis B, C or E, hemochromatosis, liver cirrhosis Child-Pugh Score B or C, primary biliary cholangitis, primary biliary cirrhosis, Morbus Wilson) a. Patients with liver metastasis are eligible 8. Patients receiving cancer treatment other than immune checkpoint inhibitors in parallel (e.g., tyrosine kinase inhibitors or chemotherapy). a. Patients who have received other cancer treatments in previous cycles are eligible, provided the treating physician does not assume any toxicity from the other medication. 9. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to occurrence of IR hepatitis. Stable corticosteroid doses of \< 10mg prednisone equivalent are allowed.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland, United Kingdom
Sponsor
University Hospital, Basel, Switzerland(Other)
Protocol no.
2025-00696
Conditions
Immune Related Adverse Events, Immune-Mediated Hepatitis, Cancer
Interventions
Drug

Treatments studied

  • Low-dose corticosteroids for immune-related hepatitis grade 3
  • Low-dose corticosteroids for immune-related hepatitis grade 2

Collaborators

Royal Marsden NHS Foundation Trust, Odense University Hospital, UMC Utrecht

Locations · 1

  • Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site

In total, worldwide, 1 of the 2 sites listed in the registry is recruiting; the other one is not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 11, 2025).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 2025 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.