Objective:To evaluate the efficacy and safety of Cidan Capsule combined with adjuvant transarterial chemoembolization(TACE) in patients with a high risk of early recurrence after curative resection of hepatocellular c...Objective:To evaluate the efficacy and safety of Cidan Capsule combined with adjuvant transarterial chemoembolization(TACE) in patients with a high risk of early recurrence after curative resection of hepatocellular carcinoma(HCC).Methods:A multicenter,randomized controlled trial was conducted in patients with high-risk recurrence factors after curative resection of HCC from 9 medical centers between July 2014 and July 2018.Totally249 patients were randomly assigned to TACE with or without Cidan Capsule administration groups by stratified block in a 1:1 ratio.Postoperative adjuvant TACE was given 4-5 weeks after hepatic resection in both groups.Additionally,125 patients in the TACE plus Cidan group were administrated Cidan Capsule(0.27 g/capsule,5 capsules every time,4 times a day) for 6 months with a 24-month follow-up.Primary endpoints included diseasefree survival(DFS) and tumor recurrence rate(TRR).Secondary endpoint was overall survival(OS).Any drugrelated adverse events(AEs) were observed and recorded.Results:As the data cutoff on July 9th,2018,the median DFS was not reached in the TACE plus Cidan group and 234.0 days in the TACE group(hazard ratio,0.420,95%confidence interval,0.290-0.608;P<0.01).The 1-and 2-year TRR in the TACE plus Cidan and TACE groups were 31.5%,37.1%,and 60.8%,63.4%,respectively(P<0.01).Median OS was not reached in both groups.The1-and 2-year OS rates in TACE plus Cidan and TACE groups were 98.4%,98.4%,and 89.5%,87.9%,respectively(P<0.05).The most common grade 3-4 AEs included fatigue,abdominal pain,lumbar pain,and nausea.One serious AE was reported in 1 patient in the TACE plus Cidan group,the death was due to retroperitoneal mass hemorrhage and hemorrhagic shock,and was not related to study drug.Conclusions:Cidan Capsule in combination with TACE can reduce the incidence of early recurrence in HCC patients at high-risk of recurrence after radical hepatectomy and may be an appropriate option in postoperative anti-recurrence treatment.(Registration No.NCT02253511)展开更多
基金Supported by National 12th Five Year“Major New Drug Creation”Science and Technology Major Project(No.20132x091022-023)。
文摘Objective:To evaluate the efficacy and safety of Cidan Capsule combined with adjuvant transarterial chemoembolization(TACE) in patients with a high risk of early recurrence after curative resection of hepatocellular carcinoma(HCC).Methods:A multicenter,randomized controlled trial was conducted in patients with high-risk recurrence factors after curative resection of HCC from 9 medical centers between July 2014 and July 2018.Totally249 patients were randomly assigned to TACE with or without Cidan Capsule administration groups by stratified block in a 1:1 ratio.Postoperative adjuvant TACE was given 4-5 weeks after hepatic resection in both groups.Additionally,125 patients in the TACE plus Cidan group were administrated Cidan Capsule(0.27 g/capsule,5 capsules every time,4 times a day) for 6 months with a 24-month follow-up.Primary endpoints included diseasefree survival(DFS) and tumor recurrence rate(TRR).Secondary endpoint was overall survival(OS).Any drugrelated adverse events(AEs) were observed and recorded.Results:As the data cutoff on July 9th,2018,the median DFS was not reached in the TACE plus Cidan group and 234.0 days in the TACE group(hazard ratio,0.420,95%confidence interval,0.290-0.608;P<0.01).The 1-and 2-year TRR in the TACE plus Cidan and TACE groups were 31.5%,37.1%,and 60.8%,63.4%,respectively(P<0.01).Median OS was not reached in both groups.The1-and 2-year OS rates in TACE plus Cidan and TACE groups were 98.4%,98.4%,and 89.5%,87.9%,respectively(P<0.05).The most common grade 3-4 AEs included fatigue,abdominal pain,lumbar pain,and nausea.One serious AE was reported in 1 patient in the TACE plus Cidan group,the death was due to retroperitoneal mass hemorrhage and hemorrhagic shock,and was not related to study drug.Conclusions:Cidan Capsule in combination with TACE can reduce the incidence of early recurrence in HCC patients at high-risk of recurrence after radical hepatectomy and may be an appropriate option in postoperative anti-recurrence treatment.(Registration No.NCT02253511)
