Evaluating Low-Dose Prednisolone for Managing Immune Checkpoint Inhibitor-Related Hepatitis in Adult Cancer Patients A Prospective Registry-Based Cohort Study

What this Trial Is About

Researchers are evaluating the use of low-dose corticosteroids to manage moderate to severe immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors. This study aims to find out if a dose of 0.5-1 mgkg prednisolone can effectively control hepatitis without needing higher doses or additional immunosuppressive treatments. The study focuses on adult cancer patients who develop grade 2 or 3 immune-related hepatitis during their immunotherapy treatment. The study involves treating patients with low-dose prednisolone adjusted according to the severity of liver enzyme elevations. For grade 3 hepatitis, prednisolone is given at 0.5-1 mgkg orally, while for grade 2, immunotherapy may be paused and prednisolone considered if liver function worsens. Patients are recruited from oncology centers using standardized treatment protocols. The study follows patients for six months after hepatitis onset, with no extra visits beyond standard care. Participants will have their liver function monitored regularly, along with their immunotherapy status, corticosteroid use, and any new immune-related side effects. Data are collected electronically to track hepatitis resolution, corticosteroid dose changes, relapse rates, survival outcomes, and predictors of steroid resistance. The primary measure is the proportion of patients whose hepatitis resolves within eight weeks without needing increased corticosteroid doses or additional immunosuppressants, aiming to inform safer and effective management guidelines.

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