Hepatic Artery Injection of ¹³¹I-Metuximab Combined with Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma: A Prospective Nonrandomized, Multicenter Clinical Trial

Abstract

This prospective nonrandomized, multicenter clinical trial was performed to investigate the efficacy and safety of ¹³¹I-labeled metuximab in adjuvant treatment of unresectable hepatocellular carcinoma. <b>Methods:</b> Patients were assigned to treatment with transcatheter arterial chemoembolization (TACE) combined with ¹³¹I-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 mo in the TACE + ¹³¹I-metuximab group (<i>n</i> = 160) and 3 mo in the TACE group (<i>n</i> = 160) (hazard ratio, 0.55; 95% CI, 0.43-0.70; <i>P</i> < 0.001). The median overall survival was 28 mo in the TACE + ¹³¹I-metuximab group and 19 mo in the TACE group (hazard ratio, 0.62; 95% CI, 0.47-0.82; <i>P</i> = 0.001). <b>Conclusion:</b> TACE + ¹³¹I-metuximab showed a greater antirecurrence benefit, significantly improved the 5-y survival of patients with advanced hepatocellular carcinoma, and was well tolerated by patients.