Zhao Yan, Bai Wei, Ding Rong, You Nan, Zheng Lin, Li Lei, Wu Jianbing, Zhang Peng, Huang Wukui, Zhang Hui, Zhang Yongjin, Zhu Diwen, Li Haiping, Xia Dongdong, Yuan Jie, Li Xiaomei, Wang Zhengyu, Luo Bohan, Guo Wengang, Yin Zhanxin, Mu Wei, Huang Ming, Li Jing, Ren Weixin, Fan Daiming, Lv Yong, Han Guohong
Department of Liver Diseases and Interventional Radiology, Xi'an International Medical Center Hospital, Northwest University, Xi'an, China.
Department of Liver Diseases and Interventional Radiology, National Clinical Research Centre for Digestive Disease, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
Liver Cancer. 2025 May 22:1-14. doi: 10.1159/000546530.
Patients with advanced hepatocellular carcinoma (HCC) face an extremely poor prognosis. Sorafenib, a multikinase inhibitor, remains an essential treatment for advanced HCC in certain clinical settings where immunotherapy is either contraindicated or unavailable. However, the survival benefit of transarterial chemoembolization (TACE) plus sorafenib remains under investigation.
The SELECT trial was a multicenter, randomized, controlled study conducted across twelve centers in China. From September 7, 2013, to December 4, 2019, 199 patients with advanced-stage HCC were randomly assigned in a 1:1 ratio to receive either TACE plus sorafenib or sorafenib monotherapy.
The median age of the study population was 55 years (IQR 46-63), with hepatic virus infection being the predominant cause of HCC. In the intention-to-treat (ITT) population, the overall survival (OS) analysis did not show a statistically significant difference between the combination and sorafenib monotherapy groups (14.9 months [95% CI: 10.5-19.3] vs. 11.9 months [95% CI: 9.0-14.8], HR 0.862, = 0.312). However, the combination therapy group demonstrated significantly improved time to progression (TTP) (10.0 months [95% CI: 6.4-13.6] vs. 5.9 months [95% CI: 3.1-8.7]; = 0.016) and post hoc progression-free survival (PFS) (8.5 months [95% CI: 6.7-10.3] vs. 5.6 months [95% CI: 4.1-7.1]; = 0.034). In predefined per-protocol analysis, the combination therapy group showed a significantly longer median OS compared to the monotherapy group (14.6 months [11.3-17.9] vs. 7.4 months [95% CI: 4.3-10.5], HR 0.539, = 0.001).
Although the combination of TACE and sorafenib did not demonstrate a significant improvement in OS in the ITT analysis, it met the secondary endpoints, including TTP and post hoc PFS. These findings provide valuable insights for the design of future trials and highlight the importance of integrating locoregional interventions with systemic therapies in the management of advanced-stage HCC.
晚期肝细胞癌（HCC）患者预后极差。索拉非尼是一种多激酶抑制剂，在免疫治疗禁忌或无法使用的某些临床情况下，仍是晚期HCC的重要治疗方法。然而，经动脉化疗栓塞术（TACE）联合索拉非尼的生存获益仍在研究中。
SELECT试验是一项在中国12个中心进行的多中心、随机、对照研究。从2013年9月7日至2019年12月4日，199例晚期HCC患者按1:1比例随机分配，分别接受TACE联合索拉非尼或索拉非尼单药治疗。
研究人群的中位年龄为55岁（四分位间距46 - 63岁），HCC的主要病因是肝病毒感染。在意向性治疗（ITT）人群中，总生存（OS）分析显示联合治疗组和索拉非尼单药治疗组之间无统计学显著差异（14.9个月[95%CI：10.5 - 19.3] vs. 11.9个月[95%CI：9.0 - 14.8]，HR 0.862，P = 0.312）。然而，联合治疗组的进展时间（TTP）显著改善（10.0个月[95%CI：6.4 - 13.6] vs. 5.9个月[95%CI：3.1 - 8.7]；P = 0.016），事后无进展生存（PFS）也显著改善（8.5个月[95%CI：6.7 - 10.3] vs. 5.6个月[95%CI：4.1 - 7.1]；P = 0.034）。在预定义的符合方案分析中，联合治疗组的中位OS显著长于单药治疗组（14.6个月[11.3 - 17.9] vs. 7.4个月[95%CI：4.3 - 10.5]，HR 0.539，P = 0.001）。
虽然在ITT分析中，TACE与索拉非尼联合治疗未显示OS有显著改善，但达到了次要终点，包括TTP和事后PFS。这些发现为未来试验的设计提供了有价值的见解，并突出了在晚期HCC管理中将局部区域干预与全身治疗相结合的重要性。
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