Clinical effect of Cidan capsule on primary hepatocellular carcinoma in 325 cases

OBJECTIVE： To observe the clinical effect of Cidan capsules, a traditional Chinese medicine applied as an antitumor drug for decades, on the treatment of primary hepatocellular carcinoma（HCC）. A two-month experiment was carried out. METHODS： A total of 325 patients with primary HCC were randomly divided into 3 groups. The 125 patients in Group A were treated with Cidan capsules exclusively. The 100 patients in Group B were treated with Cidan capsules combined with chemotherapy. And as control group, the 100 patients in Group C were treated by chemotherapy only. The efficacy of Cidan was analyzed by monitoring associated symptoms and liver function tests and measuring the levels of the NK cell, CD3, CD4, CRJ and CD8, alpha fetoprotein（AFP）. The evaluation of Cidan＇s effects on enhancing the patients＇ life quality was through clinical and pathological observations. RESULTS： The result showed that the steady rate following the standard for evaluation of Kamofsky was over 87.0% in group B, 72.0% in Group A and 57.0% in Group C, respectively. The life quality of the patients treated with Cidan capsules and chemotherapy was improved more obviously than that in Group A and C. The NK cell,CD3, CD4,CRJ and CD8 in Group C were obviously decreased, while those in Group A and Group B were without apparent vacillation. AFP descended markedly in Group A and B, but did not in Group C. CONCLUSION： Cidan capsules combined with chemotherapy had superior curative effects on primary HCC.

Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma:A Multicenter,Randomized Controlled Trial

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)