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. Methods: 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. Results: The median time to tumor recurrence was 6 mo in the TACE 1 131I-metuxi-mab group (n 5 160) and 3 mo in the TACE group (n 5 160) (hazard ratio, 0.55; 95% CI, 0.43–0.70; P, 0.001). The median overall survival was 28 mo in the TACE 1 131I-metuximab group and 19 mo in the TACE group (hazard ratio, 0.62; 95% CI, 0.47–0.82; P 5 0.001). Conclusion: TACE 1 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.