Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: A two-arm, randomised clinical trial

摘要

Purpose: There was no standard treatment for hepatocellular carcinoma with portal vein tumour thrombosis (PVTT). This prospective, randomised, two-arm clinical trial aims to investigate the feasibility, safety and effectiveness of transarterial chemoembolisation (TACE) combined with the endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus conventional TACE. Patients and methods: Eighty-five patients who met the eligibility requirements were randomly assigned to receive the treatment of TACE combined with the endovascular implantation of an iodine-125 seed strand (43 cases) or conventional TACE (42 cases). The end points were survival time, complications related to the procedure and adverse events. Results: No significant differences in baseline characteristics were observed between groups. The mean and median survival times were 221.7 ± 16.3 days [95 % confidence interval (CI) 189.8-253.6 days] and 210.0 ± 17.5 days (95 % CI 175.8-244.2 days) in group A and 155.1 ± 7.9 days (95 % CI 139.6-170.5 days) and 154.0 ± 11.2 days (95 % CI 133.2-176.0 days) in group B (P = 0.000). The 90-, 180- and 360-day cumulative survival rates were 97.6, 58.9 and 12.3 % in group A and 92.5, 30.7 and 0 % in group B (P = 0.000). Conclusion: Transarterial chemoembolisation combined with the endovascular implantation of an iodine-125 seed strand is feasible, safe and effective in the treatment for hepatocellular carcinoma with PVTT.