Efficacy analysis of transcatheter arterial chemoembolization combined with anlotinib and PD-1 inhibitors in advanced unresectable intrahepatic cholangiocarcinoma: a multicenter retrospective cohort study based on propensity score matching

Abstract Objective To investigate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with anlotinib and PD-1 inhibitors in advanced unresectable intrahepatic cholangiocarcinoma (ICC). Methods In this retrospective cohort study, clinical data were collected from 154 patients with unresectable advanced ICC treated at the First Affiliated Hospital of Zhengzhou University, Henan Cancer Hospital, and Henan Provincial People's Hospital between January 2021 and January 2025. Patients were divided into an observation group and a control group according to treatment regimen. The observation group received TACE combined with anlotinib and PD-1 inhibitors, whereas the control group received TACE combined with anlotinib. Propensity score matching (PSM) was used to evaluate clinical efficacy, survival prognosis, and the incidence of adverse reactions. Results Sixty-six patients in the observation group received TACE plus anlotinib and PD-1 inhibitors, and 88 patients in the control group received TACE plus anlotinib. After 1:1 PSM to balance age, sex, tumor size, tumor number, Child-Pugh grade, ECOG score, baseline CA19-9, and TNM stage, 51 matched pairs were created. The objective response rate (ORR) and disease control rate (DCR) in the observation group were 70.6% and 94.1%, respectively, which were significantly higher than those in the control group (41.2% and 72.5%). Median progression-free survival (PFS) and overall survival (OS) were 11.6 months and 19.9 months in the observation group, respectively, compared with 7.9 months and 10.4 months in the control group. Cox proportional hazards analysis showed that tumor size, ECOG score, and treatment modality were independent predictors of PFS and OS. Treatment-related adverse reactions were similar between the two groups, with no statistically significant difference. Conclusions Compared with TACE plus anlotinib, TACE combined with anlotinib and PD-1 inhibitors significantly prolonged survival and improved tumor response in patients with advanced ICC, with tolerable safety. This triplet regimen may serve as a preferred first-line treatment option for advanced ICC.