本研究旨在评估肝动脉灌注化疗（HAIC）和酪氨酸激酶抑制剂（TKI）联合治疗晚期肝细胞癌（HCC）的临床疗效和安全性。这项多中心回顾性研究于2020年1月至2020年1月进行。 2023 年 12 月，我们回顾了单独接受 HAIC 或联合使用 HAIC 和 TKI 治疗的晚期 HCC 患者。为了解决两组之间的初始差异，我们采用了倾向得分匹配（PSM）。肿瘤反应评估按照 RECIST 1.1 标准进行。我们比较了两个治疗组之间的生存结果，包括总生存期 (OS)、无进展生存期 (PFS) 和客观缓解率 (ORR)。对所有患者进行安全性评估。经入组审查后，138例患者接受HAIC和TKIs联合治疗（HT组），198例患者接受HAIC单药治疗（HA组），符合本研究的纳入标准。 PSM 后，107 名患者被分配到每组。与 HA 组相比，HT 组表现出更长的中位 OS（18.0 个月与 8.8 个月；风险比 [HR]，0.52，p < 0.001）。 HT 组的中位 PFS 也更长，但没有统计学意义（6.0 个月与 4.7 个月；HR，0.85，p = 0.265）。 HT 组表现出更高的 ORR（41.1% 对比 25.2%；p = 0.020）。两组之间所有不良事件 (AE) 或 3/4 级 AE 的发生率没有显着差异（任何级别：HT 为 81.2%，HA 为 78.8%，p = 0.68；3/4 级：18.1%） HT 相对于 HA 为 13.6%，p = 0.29）。重要的是，所有 AE 都是可控且可接受的。值得注意的是，两组均未发生 5 级 AE。HAIC 和 TKI 联合治疗有效延长了晚期 HCC 患者的生存期。它是 HAIC 单一疗法的更好替代方案，且安全性可控。版权所有 © 2024 Yang、Jiang、Liu、Zhang、Li、Shao 和 Zhao。

This study aimed to assess the clinical efficacy and safety of the combined approach involving hepatic arterial infusion chemotherapy (HAIC) and tyrosine kinase inhibitors (TKIs) for the treatment of advanced hepatocellular carcinoma (HCC).In this multicenter retrospective study conducted from January 2020 to December 2023, we reviewed advanced HCC patients who were treated either with HAIC alone or with a combination of HAIC and TKIs. To address initial disparities between the two groups, we employed propensity score matching (PSM). Tumor response evaluation was performed following RECIST 1.1 criteria. We compared survival outcomes, including overall survival (OS), progression-free survival (PFS), and objective response rate (ORR), between the two treatment groups. Safety assessments were conducted for all patients.Following the eligibility review, 138 patients underwent combined treatment with HAIC and TKIs (HT group), while 198 patients received HAIC monotherapy (HA group) and met the inclusion criteria for enrollment in this study. After PSM, 107 patients were assigned to each group. The HT group exhibited a longer median OS (18.0 versus 8.8 months; hazard ratio [HR], 0.52, p < 0.001) compared to the HA group. Median PFS was also longer in the HT group, although without statistical significance (6.0 versus 4.7 months; HR, 0.85, p = 0.265). The HT group demonstrated a higher ORR (41.1% versus 25.2%; p = 0.020). No significant differences were observed between the two groups in the incidence of all adverse events (AEs) or grade 3/4 AEs (any grade: 81.2% for HT versus 78.8% for HA, p = 0.68; grade 3/4: 18.1% for HT versus 13.6% for HA, p = 0.29). Importantly, all AEs were manageable and acceptable. Notably, no grade 5 AEs occurred in either group.Combination therapy involving HAIC and TKIs effectively prolonged survival in advanced HCC patients. It represented a preferable alternative to HAIC monotherapy, with manageable safety.Copyright © 2024 Yang, Jiang, Liu, Zhang, Li, Shao and Zhao.