Clinical trial · Observational
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids - A Prospective Registry-based, Cohort Study
NCT07167251CI-TRIAL-00094978MIRA-HEPrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Immune-Mediated Hepatitis | — | UNRESOLVED | — |
| Immune Related Adverse Events | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-dose corticosteroids for immune-related hepatitis grade 2 | Drug | — | UNRESOLVED |
| Low-dose corticosteroids for immune-related hepatitis grade 3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Immune-related hepatitis grade 2
- description
- Grade 2 hepatitis is defined as an elevation of Aspartate transaminase (AST) and/or Alanine aminotransferase (ALT) levels to 3-5 times the upper limit of normal, in accordance with the guidelines of the European Society for Medical Oncology.
- interventionNames
- Drug: Low-dose corticosteroids for immune-related hepatitis grade 2
- label
- Immune-related hepatitis grade 3
- description
- Grade 3 hepatitis is defined as an elevation of Aspartate transaminase and/or Alanine aminotransferase levels to 5-20 times the upper limit of normal, in accordance with the guidelines of the European Society for Medical Oncology.
- interventionNames
- Drug: Low-dose corticosteroids for immune-related hepatitis grade 3
Primary outcomes (1)
- measure
- Proportion of patients with resolution of their IR hepatitis CTCAE grade 3 within 8 weeks of onset
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.