Hepatic Artery Injection of <sup>131</sup>I-Metuximab Combined with Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma: A Prospective Nonrandomized, Multicenter Clinical Trial
Hui Chen, Gang Nan, Wei Ding, Renyou Zhai, Ming Huang, Wuwei Yang, Bao-Cai Xing, Xu Zhu, Haifeng Xu, Xiaodong Wang, Xiao‐Yong Zhang, Baorang Zhu, Peng Liu, Guang Cao, Song Gao, Chunyi Hao, Ren-Jie Yang, Jianhai Guo, Xin Zhang, Kun Gao, Kun Wang, Jianfeng Wang, Ziyu Li, Linzhong Zhu, Rong Ding, Jinhong Li, Ling Zhao, Yu-Jun Shao, Haichun Liu, Jielai Xia, Ling Wang, Ling‐Min Kong, Zhi‐Nan Chen, Huijie Bian
Abstract
This prospective non-randomized, multicenter clinical trial was performed to investigate efficacy and safety of <sup>131</sup>I-labeled metuximab in adjuvant treatment of unresectable hepatocellular carcinoma. <b>Methods:</b> Patients were assigned to treatment with transcatheter arterial chemoembolization (TACE) combined with <sup>131</sup>I-metuximab or TACE alone. The primary outcome was overall tumor recurrence. The secondary outcomes were safety and overall survival. <b>Results:</b> The median time to tumor recurrence was 6 months in the TACE+<sup>131</sup>I-metuximab group (<i>n</i> = 160) and 3 months in the TACE group (<i>n</i> = 160) (hazard ratio, 0.55; 95% confidence interval, 0.43 to 0.70; <i>P</i> < 0.001). The median overall survival was 28 months in the TACE+<sup>131</sup>I-metuximab group and 19 months in the TACE group (hazard ratio, 0.62; 95% confidence interval, 0.47 to 0.82; <i>P</i> = 0.001). <b>Conclusion:</b> TACE+<sup>131</sup>I-metuximab showed a greater anti-recurrence benefit, significantly improved the 5-year survival of patients with advanced hepatocellular carcinoma, and was well tolerated by patients.