CHILI PROJECT

Checkpoint inhibitor-induced liver injury (ChILI) is a common toxicity and leading cause of immunotherapy discontinuation. Management of immunotherapy-related liver toxicity is not evidence-based, and there are currently no tools to accurately predict who will recover quickly or can safely restart immunotherapy.

This study will be the largest multi-centre cohort study to date on ChILI and outcomes of rechallenge. It will estimate the incidence of ChILI in a real-world setting at a national level in the UK for melanoma and renal cancer patients. This will provide valuable data to assess the feasibility of a future clinical trial in the UK to provide high-quality evidence of the treatment of ChILI. The study will provide data to enable modelling of risk factors to predict patients who develop persistent liver injury, unfavorable clinical outcomes or recurrent ChILI after rechallenge. The output will be useful for clinicians to estimate risk, inform management of patients when ChILI occurs and help decision making when considering rechallenge.

We have chosen to focus on melanoma and renal cancer patients who received checkpoint inhibitors with or without targeted therapy over a 5-year period between 1st January 2018 and 31st December 2022. Patients with concurrent chemotherapy are excluded.

We aim to commence recruitment to this project in June 2023.