Transarterial chemoembolization (TACE) is currently the recommended treatment for hepatocellular carcinoma (HCC). However, long-term chemoembolization triggers the inflammatory response and may lead to postembolization syndrome (PES). Although several types of degradable microspheres have been developed to reduce drug toxicity and PES incidence, the clinical outcomes remain unsatisfactory. Previously, we have developed a new type of spherical, calibrated, biodegradable, radiopaque microspheres (SCBRM) and demonstrated their safety and efficacy in a pig model. Thus, the goal of this feasibility study was to determine the clinical safety and efficacy of the new SCBRM in intermediate-stage HCC patients. In this study, 12 intermediate-stage HCC patients underwent TACE using SCBRM with a calibrated size of 100-250 μm. The disease control rates at 1 month and 3 months after TACE-SCBRM treatment were 100% and 75.0%, respectively. The objective response rates at 1 month and 3 months after treatment were 66.7% and 58.3%, respectively. Very few adverse events were observed with one patient developing nausea. One day after the treatment, alanine aminotransferase, alanine aminotransferase, and total bilirubin levels were slightly elevated in the patients, but all returned to baseline on day 7. The median and mean overall survival times were 33 months (interquartile range, 12.8-42.0) and 29.2 ± 14.3 months, respectively. The 1-year and 2-year survival rates were 91.7% and 58.3%, respectively. In conclusion, TACE with the new SCBRM microspheres is clinically safe and effective, and it represents a promising approach in the management of intermediate-stage HCC.

中文翻译：

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新型栓塞微球 SCBRM 治疗中期肝细胞癌的安全性和有效性：可行性研究。

经动脉化疗栓塞（TACE）是目前推荐的肝细胞癌（HCC）治疗方法。然而，长期化疗栓塞会引发炎症反应，并可能导致栓塞后综合征 (PES)。尽管已经开发了几种类型的可降解微球来降低药物毒性和 PES 发生率，但临床结果仍然不令人满意。此前，我们开发了一种新型球形、校准、可生物降解、不透射线的微球 (SCBRM)，并在猪模型中证明了它们的安全性和有效性。因此，这项可行性研究的目标是确定新 SCBRM 在中期 HCC 患者中的临床安全性和有效性。在这项研究中，12 名中期 HCC 患者使用 SCBRM 进行了 TACE，校准尺寸为 100-250 μm。TACE-SCBRM治疗后1个月和3个月的疾病控制率分别为100%和75.0%。治疗后1个月和3个月的客观缓解率分别为66.7%和58.3%。观察到的不良事件非常少，一名患者出现恶心。治疗1天后，患者的丙氨酸氨基转移酶、丙氨酸氨基转移酶和总胆红素水平略有升高，但在第7天均恢复到基线水平。中位和平均总生存时间为33个月（四分位距，12.8-42.0）和 29.2 ± 14.3 个月，分别。1年和2年生存率分别为91.7%和58.3%。总之，采用新型 SCBRM 微球的 TACE 在临床上是安全有效的，是治疗中期 HCC 的一种有前景的方法。