Transarterial chemoembolization plus an immune checkpoint inhibitor versus systemic chemotherapy plus an immune checkpoint inhibitor as a first-line treatment for unresectable intrahepatic cholangiocarcinoma: a multi-center retrospective cohort study

This multicenter retrospective cohort study was conducted to explore the efficacy and safety of transarterial chemoembolization (TACE) combined with an immune checkpoint inhibitor (ICI) versus systemic chemotherapy combined with an ICI as a first-line treatment for unresectable intrahepatic cholangiocarcinoma (iCCA). A multi-center retrospective analysis was conducted using the clinical data of advanced iCCA patients who underwent treatment from January 2022 to December 2024. The patients were divided into two groups: TACE plus ICI (TACE-ICI group) and systemic chemotherapy plus ICI (chemotherapy-ICI group). The primary endpoints were the objective response rate (ORR), the disease control rate (DCR), the overall survival (OS), and the progression-free survival (PFS). The secondary endpoint was defined as the incidence of treatment-related adverse events (AEs). The therapeutic response was evaluated according to the immune-modified Response Evaluation Criteria in Solid Tumors. The OS and PFS were calculated utilizing the Kaplan–Meier method, and the OS and PFS risk factors were evaluated using univariate and multivariate Cox proportional hazard regression analyses. Fifty-one patients received the gemcitabine-based TACE plus an immune checkpoint inhibitor (TACE-ICI group), and 40 patients received the gemcitabine-based systemic chemotherapy plus an immune checkpoint inhibitor (chemotherapy-ICI group). The median OS values in the TACE-ICI and chemotherapy-ICI group were 16.2 months and 14.0 months, respectively (P = 0.162). The median PFS values in the TACE-ICI and chemotherapy-ICI group were 12.5 and 10.6 months, respectively (P = 0.147). The ORR and DCR values in the TACE-ICI group were 27.5% and 90.2%, respectively, and they were 30.0% and 87.5% in the chemotherapy-ICI group, respectively (P = 0.789, P = 0.683). The CA19-9 of ≥ 200 U/mL and the monocyte to lymphocyte ratio were identified as independent predictors of a worse OS for patients in the TACE-ICI group. The CA 19–9 of ≥ 200 U/mL and the tumor number > 2 were identified as independent predictors of a worse OS for patients in the chemotherapy-ICI group. The severity of adverse events did not significantly differ between two groups. Gemcitabine-based TACE or systemic chemotherapy in combination with ICIs was well tolerated and provided promising therapeutic outcomes for advanced iCCA patients.