为了确定用注射CalliSpheres®胶珠负载三氧化二砷进行经动脉化疗栓塞治疗（CBATO-TACE）在大型（最大直径5 cm ≤ < 10 cm）或巨大（最大直径≥ 10 cm）肝细胞癌（HCC）患者中的安全性和疗效，本研究将患者随机分组成CBATO-TACE组和传统经动脉化疗栓塞（cTACE）组。主要终点是无进展生存期（PFS），次要终点是总生存期（OS）、治疗反应和与治疗相关的不良事件（TRAEs）。此外，还评估了第一次TACE后的肝外侧支动脉、肝功能和肝纤维化情况。 从2018年9月至2020年9月，共有207名接受TACE的患者连续入组本研究。CBATO组中，中位PFS为9.5个月（范围：8.0-11.0），明显长于cTACE组的PFS（6.0个月，范围：4.0-6.0）（p < 0.0001）。CBATO组的中位OS为22个月（范围：20.0-27.0），而cTACE组为16个月（范围：15.0-20.0）（p = 0.0084）。最常见的TRAEs是发热（p = 0.043）以及恶心和呕吐（p = 0.002），这些在cTACE组中更为常见。此外，CBATO组的进行性疾病时间、肺转移率（p = 0.01）、肝外侧支动脉平均数（p = 0.01）和平均TACE会话次数（p = 0.025）均显著降低。 CBATO-TACE在大型或巨大HCC患者中取得了更好的治疗效果和相似的安全性。此外，CBATO-TACE能够减少肝外侧支动脉形成和肺外转移。 我们的研究显示，注射CalliSpheres®胶珠负载三氧化二砷（CBATO-TACE）对于治疗大型和巨大HCC是有效和安全的。此外，CBATO-TACE可以减少侧支血管的形成和肺外转移，为不能手术切除的HCC提供了一种新的治疗方法。 ·我们比较了大型（5 cm ≤ 最大直径 < 10 cm）或巨大（最大直径≥ 10 cm）HCC患者中注射CalliSpheres®胶珠负载三氧化二砷的经动脉化疗栓塞（CBATO-TACE）和传统经动脉化疗栓塞（cTACE）的长期疗效和安全性。 ·与cTACE相比，CBATO-TACE显著改善了大型或巨大HCC患者的治疗效果、总生存期和无进展生存期。安全性评估表明，CBATO-TACE是一种安全的治疗方法，可以改善生活质量并具有良好的治疗依从性。 © 2023年作者（经欧洲放射医学学会独家许可）。

To determine the safety and efficacy of transcatheter arterial chemoembolization with CalliSpheres® beads loaded with arsenic trioxide (CBATO-TACE) in the first-line treatment of patients with large (5 cm ≤ maximum diameter < 10 cm) or huge (maximum diameter ≥ 10 cm) hepatocellular carcinoma (HCC).Patients were randomly allocated to the CBATO-TACE group and the conventional transcatheter arterial chemoembolization (cTACE) group. The primary endpoint was progression-free survival (PFS). The secondary endpoint was overall survival (OS), treatment response, and treatment-related adverse events (TRAEs). The extrahepatic collateral arteries, liver function, and liver fibrosis after the first TACE were also evaluated.From September 2018 to September 2020, a total of 207 patients who underwent TACE were consecutively enrolled in this study. The median PFS was 9.5 months (range: 8.0 - 11.0) in the CBATO group, which was significantly longer than that in the cTACE group (6.0 months, range: 4.0-6.0) (p < 0.0001). Patients in the CBATO group had a median OS of 22 months (range: 20.0 - 27.0) compared with 16 months (range: 15.0 - 20.0) in the cTACE group (p = 0.0084). The most common TRAEs were fever (p = 0.043), and nausea and vomiting (p = 0.002), which were more observed in the cTACE group. In addition, the progressive disease time, pulmonary metastasis rate (p = 0.01), the mean number of extrahepatic collateral arteries (p = 0.01), and average number of TACE sessions (p = 0.025) were significantly decreased in the CBATO group.CBATO-TACE achieved better therapeutic outcomes and similar safety profile compared to cTACE in large or huge HCC patients. Furthermore, CBATO-TACE was able to reduce extrahepatic collateral arteries production and extrahepatic lung metastasis.Our study showed that CalliSpheres® beads loaded with arsenic trioxide (CBATO-TACE) were effective and safe for the treatment of large and giant HCC. In addition, CBATO-TACE can reduce lateral hepatic branch artery formation and extrahepatic pulmonary metastasis, which provides a new treatment approach for unresectable HCC.• We compare long-term efficacy and safety of transcatheter arterial chemoembolization with CalliSpheres® beads loaded with arsenic trioxide (CBATO-TACE) and conventional transcatheter arterial chemoembolization (cTACE) in patients with large (5 cm ≤ maximum diameter < 10 cm) or huge HCC (maximum diameter ≥ 10 cm). • Compared with cTACE, CBATO-TACE significantly improved therapeutic outcomes, overall survival, and progression-free survival in patients with large or huge HCC. The safety assessment suggested that CBATO-TACE is a safe treatment that improves the quality of life and has good treatment adherence.© 2023. The Author(s), under exclusive licence to European Society of Radiology.