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.

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.