Checkpoint Inhibitor-induced Liver Injury

Inclusion Criteria12

• Both patient groups and control group:
• Able to give written informed consent OR Potential participants who have developed encephalopathy related to ChILI as a response to checkpoint inhibitor therapy, who lack the capacity to give written informed consent and have a consultee (personal or nominated) - for ChILI patient group only
• ChILI group:
• Patients who developed checkpoint inhibitor-induced liver injury and meet the following criteria:
• Meets one of the following analytical thresholds at enrolment (visit 1)
• Alanine transaminase (ALT) exceeding 5 times the upper limit of normal (ULN) OR
• ALT exceeding 3 times ULN plus bilirubin exceeding 2 times ULN OR
• Alkaline phosphatase (ALP) exceeding 2 times ULN with accompanying elevations of gamma-glutamyl transferase in the absence of known bone metastases driving the rise in ALP level
• Absence of other known causes of liver injury after detailed investigations
• Patients who developed ChILI but did not meet the above criteria at enrolment or who were found to have a different cause for their liver injury after further investigations will be excluded from the analysis
• Control group:
• Consecutive patients with cancer who have a clinical indication to start checkpoint inhibitors. A small proportion of patients will develop ChILI following their checkpoint inhibitor treatment and will be classified as cases.