PMID- 35915317 OWN - NLM STAT- MEDLINE DCOM- 20221223 LR - 20221223 IS - 1993-0402 (Electronic) IS - 1672-0415 (Linking) VI - 29 IP - 1 DP - 2023 Jan TI - Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Trial. PG - 3-9 LID - 10.1007/s11655-022-3537-4 [doi] AB - 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. 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. RESULTS: 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. 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). CI - (c) 2022. The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Zheng, Dong-Hai AU - Zheng DH AD - Department of Oncology, Beijing Weida Traditional Chinese Medicine Cancer Hospital, Beijing, 100023, China. FAU - Yang, Jia-Mei AU - Yang JM AD - Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai, 200433, China. FAU - Wu, Jian-Xiong AU - Wu JX AD - Department of Abdominal Surgery, Cancer Hospital of Chinese Academy of Medical Sciences, Beijing, 100021, China. dr_wujx@163.com. FAU - Cheng, Shu-Qun AU - Cheng SQ AD - Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai, 200433, China. FAU - Zhang, Shao-Geng AU - Zhang SG AD - Department of Hepatic Surgery, the Fifth Medical Center of PLA General Hospital, Beijing, 100161, China. FAU - Wu, Dong AU - Wu D AD - Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai, 200433, China. FAU - Li, Ai-Jun AU - Li AJ AD - Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai, 200433, China. FAU - Fu, Xiao-Hui AU - Fu XH AD - Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai, 200433, China. FAU - Li, Xun AU - Li X AD - Department of Hepatic Surgery, the First Hospital of Lanzhou University, Lanzhou, 730013, China. FAU - Qi, Fu-Chen AU - Qi FC AD - Department of Hepatic Surgery, Huai'an First People's Hospital, Nanjing Medical University, Huai'an, Jiangsu Province, 223399, China. FAU - Duan, Wei-Hong AU - Duan WH AD - Department of Hepatic Surgery, PLA Rocket Army General Hospital, Beijing, 100088, China. FAU - Chen, Jun-Hui AU - Chen JH AD - Department of Interventional Therapy, Shenzhen Hospital of Peking University, Shenzhen, Guangdong Province, 518036, China. FAU - Yang, Zhi-Ying AU - Yang ZY AD - Department of Hepatic Surgery, China-Japan Friendship Hospital, Beijing, 100029, China. FAU - Liang, Lu AU - Liang L AD - Department of Hepatic Surgery, Baotou Central Hospital, Baotou, Inner Mongolia Autonomous Region, 014042, China. FAU - Zeng, Jin-Xiong AU - Zeng JX AD - Department of Traditional Chinese Medicine, No. 900 Hospital of the Joint Logistics Support Force of PLA, Fuzhou, 350025, China. FAU - Zheng, Wei-da AU - Zheng WD AD - Department of Oncology, Beijing Weida Traditional Chinese Medicine Cancer Hospital, Beijing, 100023, China. zdhzdl@126.com. FAU - Wu, Meng-Chao AU - Wu MC AD - Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai, 200433, China. LA - eng SI - ClinicalTrials.gov/NCT02253511 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20220801 PL - China TA - Chin J Integr Med JT - Chinese journal of integrative medicine JID - 101181180 SB - IM MH - Humans MH - *Carcinoma, Hepatocellular/drug therapy/surgery MH - *Liver Neoplasms/drug therapy/pathology MH - *Chemoembolization, Therapeutic/adverse effects MH - Hepatectomy MH - Disease-Free Survival MH - Treatment Outcome MH - Retrospective Studies OTO - NOTNLM OT - Cidan Capsule OT - hepatectomy OT - hepatocellular carcinoma OT - recurrence OT - survival OT - transarterial chemoembolization EDAT- 2022/08/02 06:00 MHDA- 2022/12/24 06:00 CRDT- 2022/08/01 23:29 PHST- 2022/04/20 00:00 [accepted] PHST- 2022/08/02 06:00 [pubmed] PHST- 2022/12/24 06:00 [medline] PHST- 2022/08/01 23:29 [entrez] AID - 10.1007/s11655-022-3537-4 [pii] AID - 10.1007/s11655-022-3537-4 [doi] PST - ppublish SO - Chin J Integr Med. 2023 Jan;29(1):3-9. doi: 10.1007/s11655-022-3537-4. Epub 2022 Aug 1.