NCT07167251 Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
| NCT ID | NCT07167251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Immune Related Adverse Events |
| Study Type | OBSERVATIONAL |
| Enrollment | 63 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 63 participants in total. It began in 2025-08-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Andreas M Schmitt, MD
PRINCIPAL INVESTIGATOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT07167251 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune Related Adverse Events. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07167251 currently recruiting?
Yes, NCT07167251 is actively recruiting participants. Contact the research team at andreasmichael.schmitt@usb.ch for enrollment information.
Where is the NCT07167251 trial being conducted?
This trial is being conducted at Basel, Switzerland, London, United Kingdom.
Who is sponsoring the NCT07167251 clinical trial?
NCT07167251 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Andreas M Schmitt, MD at University Hospital, Basel, Switzerland. The trial plans to enroll 63 participants.