MSOR4  Presentation Time: 5:00 PM: Stent Placement Plus Radioactive Seeds Implantation for the Treatment of Portal Vein Tumor Thrombosis

Purpose Treatment strategy of hepatocellular carcinoma (HCC) and Vp4 [main trunk] portal vein tumor thrombosis (PVTT) remains limited due to post treatment liver failure. We aimed to assess the efficacy of irradiation stent placement with 125I plus transcatheter arterial chemoembolization (TACE) (ISP-TACE) compared to sorafenib plus TACE (Sora-TACE) in these patients. Materials and Methods In this multicenter randomized controlled trial, participants with HCC and Vp4 PVTT without extrahepatic metastases were enrolled from November 2018 to July 2021 at 16 medical centers. The primary endpoint was overall survival (OS). The secondary endpoints were hepatic function, time to symptomatic progression, patency of portal vein, disease control rate, and treatment safety. Results Of 105 randomized participants, 51 were assigned to the ISP-TACE group, 54 were assigned to the Sora-TACE group. The median OS was 9.9 months vs 6.3 months (95% CI: 0.27, 0.82; P = .01). Incidence of acute hepatic decompensation was 16% (8 of 51) vs 33% (18 of 54) (P = .036). The time to symptomatic progression was 6.6 months vs 4.2 months (95% CI: 0.38,0.93; P = .037). The median stent patency was 7.2 months (interquartile range, 4.7-9.3) in the ISP-TACE group. The disease control rate was 86% (44 of 51) vs 67% (36 of 54) (P = .018). Incidences of adverse events ≥ grade 3 were comparable between the safety populations of the two groups: 16 of 49 (33%) vs 18 of 50 (36%) (P = .73). Conclusion Irradiation stent placement plus TACE showed superior results compared with sorafenib plus TACE in prolonging OS in patients with HCC and Vp4 PVTT. Treatment strategy of hepatocellular carcinoma (HCC) and Vp4 [main trunk] portal vein tumor thrombosis (PVTT) remains limited due to post treatment liver failure. We aimed to assess the efficacy of irradiation stent placement with 125I plus transcatheter arterial chemoembolization (TACE) (ISP-TACE) compared to sorafenib plus TACE (Sora-TACE) in these patients. In this multicenter randomized controlled trial, participants with HCC and Vp4 PVTT without extrahepatic metastases were enrolled from November 2018 to July 2021 at 16 medical centers. The primary endpoint was overall survival (OS). The secondary endpoints were hepatic function, time to symptomatic progression, patency of portal vein, disease control rate, and treatment safety. Of 105 randomized participants, 51 were assigned to the ISP-TACE group, 54 were assigned to the Sora-TACE group. The median OS was 9.9 months vs 6.3 months (95% CI: 0.27, 0.82; P = .01). Incidence of acute hepatic decompensation was 16% (8 of 51) vs 33% (18 of 54) (P = .036). The time to symptomatic progression was 6.6 months vs 4.2 months (95% CI: 0.38,0.93; P = .037). The median stent patency was 7.2 months (interquartile range, 4.7-9.3) in the ISP-TACE group. The disease control rate was 86% (44 of 51) vs 67% (36 of 54) (P = .018). Incidences of adverse events ≥ grade 3 were comparable between the safety populations of the two groups: 16 of 49 (33%) vs 18 of 50 (36%) (P = .73). Irradiation stent placement plus TACE showed superior results compared with sorafenib plus TACE in prolonging OS in patients with HCC and Vp4 PVTT.