Zheng Dong-Hai, Yang Jia-Mei, Wu Jian-Xiong, Cheng Shu-Qun, Zhang Shao-Geng, Wu Dong, Li Ai-Jun, Fu Xiao-Hui, Li Xun, Qi Fu-Chen, Duan Wei-Hong, Chen Jun-Hui, Yang Zhi-Ying, Liang Lu, Zeng Jin-Xiong, Zheng Wei-da, Wu Meng-Chao
Department of Oncology, Beijing Weida Traditional Chinese Medicine Cancer Hospital, Beijing, 100023, China.
Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai, 200433, China.
Chin J Integr Med. 2023 Jan;29(1):3-9. doi: 10.1007/s11655-022-3537-4. Epub 2022 Aug 1.
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).
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. Totally 249 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 disease-free survival (DFS) and tumor recurrence rate (TRR). Secondary endpoint was overall survival (OS). Any drug-related adverse events (AEs) were observed and recorded.
As the data cutoff in 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. The 1- 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.
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).
评估慈丹胶囊联合肝动脉化疗栓塞术（TACE）对肝细胞癌（HCC）根治性切除术后早期复发高危患者的疗效和安全性。
2014年7月至2018年7月期间，在9个医学中心对HCC根治性切除术后具有高危复发因素的患者进行了一项多中心随机对照试验。总共249例患者按1:1比例通过分层区组随机分配至接受或不接受慈丹胶囊给药的TACE组。两组均在肝切除术后4 - 5周进行术后辅助TACE。此外，TACE加慈丹组的125例患者服用慈丹胶囊（0.27 g/粒，每次5粒，每日4次），持续6个月，并进行24个月的随访。主要终点包括无病生存期（DFS）和肿瘤复发率（TRR）。次要终点是总生存期（OS）。观察并记录任何与药物相关的不良事件（AE）。
截至2018年7月9日数据截止时，TACE加慈丹组未达到中位DFS，TACE组为234.0天（风险比，0.420；95%置信区间，0.290 - 0.608；P < 0.01）。TACE加慈丹组和TACE组的1年和2年TRR分别为31.5%、37.1%和60.8%、63.4%（P < 0.01）。两组均未达到中位OS。TACE加慈丹组和TACE组的1年和2年OS率分别为98.4%、98.4%和89.
