Low-dose prednisolone for immune checkpoint inhibitor–related hepatitis
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study
This project will try low-dose prednisolone (0.5–1 mg/kg) to manage grade 2–3 immune-related hepatitis in adults receiving immune checkpoint inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | chemotherapy, prednisone, immunotherapy |
| Locations | 2 sites (Basel, Canton of Basel-City and 1 other locations) |
| Trial ID | NCT07167251 on ClinicalTrials.gov |
What this trial studies
This prospective, registry-based cohort study enrolls adult cancer patients who develop grade 2–3 immune-related hepatitis while on PD-1, PD-L1, CTLA-4, LAG-3, or combination therapy. Participants receive a predefined low-dose prednisolone 'test dose' (0.5–1 mg/kg) with early clinical and laboratory reassessment to determine response and need for escalation. The study tracks control of hepatitis without higher-dose steroids or additional immunosuppression, steroid-related adverse events, and the ability to continue cancer immunotherapy. Data are collected across multiple European oncology centers using standardized management protocols.
Who should consider this trial
Good fit: Adult cancer patients on PD-1/PD-L1, CTLA-4, LAG-3, or combination immune checkpoint inhibitors who develop investigator‑judged grade 2–3 immune-related hepatitis and who have not already received high‑dose corticosteroids are the intended participants.
Not a fit: Patients presenting with grade 4 hepatitis, bilirubin >1.5×ULN, clinical suspicion of cholangitis, elevated INR beyond baseline, prior systemic treatment for immune-related hepatitis, or those who already received >0.5 mg/kg corticosteroids are unlikely to benefit from this low‑dose approach.
Why it matters
Potential benefit: If successful, this approach could let many patients control hepatitis with lower steroid doses, reducing infections and other steroid harms while better preserving cancer treatment.
How similar studies have performed: Retrospective reports suggest lower corticosteroid doses can control some immune‑related hepatitis cases, but prospective evidence is limited and this targeted low‑dose strategy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basel, Canton of Basel-City and 1 other locations
- University Hospital Basel — Basel, Canton of Basel-City, Switzerland (Recruiting)
- Royal Marsden Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Andreas M Schmitt, MD — University Hospital, Basel, Switzerland
- Study coordinator: Andreas M Schmitt, MD
- Email: andreasmichael.schmitt@usb.ch
- Phone: +41 61 265 50 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.