为了回顾性评估和比较经肝动脉化疗栓塞联合分子靶向药物和免疫检查点抑制剂（TACE+T+I）与经肝动脉化疗栓塞联合分子靶向药物（TACE+T）治疗不可切除型肝细胞癌（uHCC）的疗效和安全性。我们回顾性分析了2018年1月至2022年6月间不可切除的HCC患者的数据。根据纳入标准筛选患者，并将其分为三联合组（TACE+T+I）和双联合组（TACE+T）。主要结局指标包括总生存期（OS）、无进展生存期（PFS）和不良事件（AEs）。次要结局指标包括客观缓解率（ORR）和疾病控制率（DCR）。通过Cox回归分析确定与PFS和OS相关的危险因素。 本研究共纳入87例患者，其中TACE+T+I组42例，TACE+T组45例。在中位随访时间为29.00和26.70个月的情况下，接受TACE+T+I疗法的患者显著获得了较长的中位OS（24.00 vs. 21.40个月，p = 0.007）和中位PFS（9.70 vs. 7.00个月，p = 0.017）；两组中没有发生4级AEs或治疗相关死亡。两组中与系统药物相关的3级AEs没有显著差异（19.0% vs. 15.6%，p = 0.667）。与TACE+T组相比，TACE+T+I组的患者在肿瘤反应方面表现更好，ORR为52.4% vs. 17.8%（p = 0.001）。两组之间的DCR没有显著差异（83.3% vs. 77.8%，p = 0.514）。Cox回归分析显示，只有治疗方法是OS的独立因素，年龄和治疗方法都是与PFS相关的独立因素。 与TACE加分子靶向药物（TACE+T）相比，三重治疗（TACE+T+I）可以改善不可切除HCC患者的生存和肿瘤反应，并且毒副反应可控。版权所有© 2023 Jiang, Zhong, Huang, Li, Zhang, Zhu, Ni and Shen.

To retrospectively evaluate and compare treatment effectiveness and safety between transarterial chemoembolization (TACE) combined with molecularly targeted agents plus immune checkpoint inhibitors (TACE+T+I) and TACE combined with molecularly targeted agents (TACE+T) for unresectable hepatocellular carcinoma (uHCC).We retrospectively analyzed the data of patients with unresectable HCC from January 2018 to June 2022. The patients were screened based on the inclusion criteria and were divided into the triple combination group (TACE+T+I) and the double combination group (TACE+T). The primary outcomes were overall survival (OS), progression-free survival (PFS), and adverse events (AEs). The secondary outcomes were objective response rate (ORR) and disease control rate (DCR). Risk factors associated with PFS and OS were determined by Cox regression analysis.A total of 87 patients were enrolled in this study, including 42 patients in the TACE+T+I group and 45 patients in the TACE+T group. Over a median follow-up of 29.00 and 26.70 months, patients who received TACE+T+I therapy achieved a significantly longer median OS (24.00 vs. 21.40 months, p = 0.007) and median PFS (9.70 vs. 7.00 months, p = 0.017); no grade 4 AEs or treatment-related death occurred in the two groups. Grade 3 AEs attributed to systemic agents in the two groups showed no significant difference (19.0% vs. 15.6%, p = 0.667). Patients in the TACE+T+I group demonstrated better tumor response when compared with patients in the TACE+T group, with an ORR of 52.4% vs. 17.8% (p = 0.001). No significant difference was observed in DCR between the two groups (83.3% vs. 77.8%, p = 0.514). Cox regression analysis showed that only the treatment method was an independent factor of OS, and both age and treatment method were independent factors related to PFS.Compared with TACE plus molecularly targeted agents (TACE+T), the triple therapy (TACE+T+I) could improve survival and tumor response in unresectable HCC with manageable toxicities.Copyright © 2023 Jiang, Zhong, Huang, Li, Zhang, Zhu, Ni and Shen.