Abstract: Objective The aim of this study was to investigate the risk factors for immune checkpoint inhibitors (ICIs)-associated liver injury in patients with malignant tumors. Methods A total of 337 consecutive patients with malignant tumors were admitted to our hospital between January and December 2024. All of them received anti-tumor treatment containing ICIs or ICIs with combination of other anti-tumor medicines. Multivariate Logistic regression analysis was applied to identify the risk factors for ICIs-associated liver injury in the patients. Results Of the 337 patients with malignant tumor, 31 (9.2%) patients developed ICIs-associated liver injury during anti-tumor treatment; the proportions of patients at tumor stage IV, the application of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor and with a chronic liver disease history in the liver injury group were 67.7%, 25.8% and 32.2%, all significantly higher than 45.1%, 9.2% and 13.1% (P<0.05) in those without iver injury group; multivariate Logistic regression analysis showed that tumor stage (OR=2.700, 95%CI: 1.172-6.223, P<0.05), CTLA-4 inhibitor administration (OR=1.740, 95%CI: 1.052-2.880, P<0.05) and liver disease history (OR=3.619, 95%CI: 1.486-8.815, P<0.05) were the independent risk factors for occurrence of ICIs-associated liver injury in patients with malignant tumors. Conclusion Clinicians should take risk factors into consideration in order to prevent and early management of ICIs-associated liver injury.

Key words: Drug-induced Liver injury, Malignant tumor, Immune checkpoint inhibitors, Risk factor