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

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

doi:10.1007/s11655-022-3537-4

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

Original Article | Updated：2023-01-05

- Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma:A Multicenter, Randomized Controlled Trial
- Chinese Journal of Integrative Medicine Vol. 29, Issue 1, Pages: 3-9(2023)
- Affiliations：
  
  1.Department of Oncology, Beijing Weida Traditional Chinese Medicine Cancer Hospital, Beijing (100023), China
  2.Department of Hepatic Surgery, the Third Affiliated Hospital of Naval Medical University, Shanghai (200433), China
  3.Department of Abdominal Surgery, Cancer Hospital of Chinese Academy of Medical Sciences, Beijing (100021), China
  4.Department of Hepatic Surgery, the Fifth Medical Center of PLA General Hospital,Beijing (100161), China
  5.Department of Hepatic Surgery, the First Hospital of Lanzhou University, Lanzhou (730013), China
  6.Department of Hepatic Surgery, Huai'an First People's Hospital,Nanjing Medical University, Huai'an, Jiangsu Province (223399),China
  7.Department of Hepatic Surgery, PLA Rocket Army General Hospital, Beijing (100088), China
  8.Department of Interventional Therapy, Shenzhen Hospital of Peking University, Shenzhen,Guangdong Province (518036), China
  9.Department of Hepatic Surgery, China-Japan Friendship Hospital, Beijing (100029), China
  10.Department of Hepatic Surgery, Baotou Central Hospital,Baotou, Inner Mongolia Autonomous Region (014042), China
  11.Department of Traditional Chinese Medicine, No. 900 Hospital of the Joint Logistics Support Force of PLA, Fuzhou (350025), China
- Author bio：
  
  Dr. WU Jian-xiong, E-mail: dr_wujx@163.com
  Dr. ZHENG Wei-da, E-mail: zdhzdl@126.com;
- Funds：
- DOI：10.1007/s11655-022-3537-4
  CLC：
- Published：01 January 2023，
  
  Published Online：01 August 2022，
  
  Accepted：20 April 2022
Scan for full text
ZHENG Dong-hai, YANG Jia-mei, WU Jian-xiong, et al. Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma:A Multicenter, Randomized Controlled Trial. [J]. Chinese Journal of Integrative Medicine 29(1):3-9(2023)
DOI：

ZHENG Dong-hai, YANG Jia-mei, WU Jian-xiong, et al. Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma:A Multicenter, Randomized Controlled Trial. [J]. Chinese Journal of Integrative Medicine 29(1):3-9(2023) DOI： 10.1007/s11655-022-3537-4.

摘要

Abstract

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 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;

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 (

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 (

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)

关键词

Keywords

hepatocellular carcinomahepatectomyrecurrencesurvivaltransarterial chemoembolizationCidan Capsule

references

Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, et al. Hepatocellular carcinoma. Nat Rev Dis Primers 2021;7:7.

Benson AB, D'Angelica MI, Abbott DE, Abrams TA, Alberts SR,Anaya DA, et al. Guidelines insights: hepatobiliary cancers,version 2. 2019. J Natl Compr Canc Netw 2019;17:302-310.

Du Y, Su T, Ding Y, Cao G. Effects of antiviral therapy on the recurrence of hepatocellular carcinoma after curative resection or liver transplantation. Hepat Mon 2012;12:e6031.

Dong ZR, Zhang PF, Wang CH, Zhang C, Cai JB, Shi GM, et al.Postoperative adjuvant transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinomas beyond the Milan criteria: a retrospective analysis. Am J Cancer Res 2014;5:450-457.

Jia F. Progress in diagnosis, treatment, and clinical research of liver cancer in China. Chin J Pract Surg (Chin) 2019;10:17.

Marrero JA, Kulik LM, Sirlin CB, Zhu AX, Finn RS, Abecassis MM, et al. Diagnosis, staging, and management of hepatocellular carcinoma: 2018 practice guidance by the American Association for the Study of Liver Diseases. Hepatology 2018;68:723-750.

Liu GF, Li F, Bi XJ, Zhu BH. Systematic review of clinical effects of Cidan Capsules combined with TACE in treatment against primary liver cancer. Chin J Hosp Pharm (Chin) 2016;36:1496-1500.

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE,McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-655.

Zhang Y, Zhang M, Chen M, Mei J, Xu L, Guo R, et al. Association of sustained response duration with survival after conventional transarterial chemoembolization in patients with hepatocellular carcinoma. JAMA Netw Open 2018;1:e183213.

Bruix J, Takayama T, Mazzaferro V, Chau GT, Yang JM, Kudo M, et al. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM) a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol 2015;16:1344-1354.

Zhang XP, Wang K, Wang M, Yang G, Ye XF, Wu MC, et al.Transarterial chemoembolization (TACE) combined with sorafenib versus TACE for hepatocellular carcinoma with portal vein tumor thrombus: a systematic review and meta-analysis.Oncotarget 2017;8:29416-29427.

Ling CQ. Experiences on the establishment of series clinical programs for the treatment of primary liver cancer by integrated traditional Chinese and Western medicine. Chin J Integr Tradit West Med (Chin) 2019;39:1166-1168.

Xi SY, Minuk GY. Role of traditional Chinese medicine in the management of patients with hepatocellular carcinoma. World J Hepatol 2018;10:799-806.

Zheng WD, Zheng DH, Zheng WH. Clinical summarization of Cidan Capsule in treating 325 cases of primary liver cancer.Shanghai J Tradit Chin Med (Chin) 2002;12:8.

Liu JY, He C, Tang Y, Liu WD, Xu Y, Li ZL, et al. A review of Cremastra appendiculata (D.Don) Makino as a traditional herbal medicine and its main components. J Ethnopharmacol 2021;279:114357.

Chen XP, Pei LX, Zhong ZF, Guo JJ, Zhang QW, Wang YT. Anti-tumor potential of ethanol extract of Curcuma phaeocaulis Valeton against breast cancer cells. J Phytomed 2011;18:1238-1243.

Li K, Liang YY, Wang Q, Li Y, Zhou SJ, Wei HC, et al.Brucea javanica: a review on anticancer of its pharmacological properties and clinical researches. J Phytomed 2021;86:153560.

Rao PS, Ramanadham M, Prasad MN. Anti-proliferative and cytotoxic effects of Strychnos nux-vomica root extract on human multiple myeloma cell line—RPMI 8226. Food Chem Toxicol 2009;47:283-288.

Chen XP, Guo JJ, Bao JL, Lu JJ, Wang YT. The anticancer properties of Salvia Miltiorrhiza Bunge (Danshen): a systematic review. Medl Res Rev 2014;34:768-794.

Wang JX, Zhou CF, Zheng WD. Clinical effect of Cidan Capsule on patients with primary hepatocellular carcinoma. World J Integr Tradit West Med (Chin) 2006;1:160-162.

Li N, Zheng DH, Xue J, Guo WX, Shi J, Sun JX, et al. Cidan inhibits liver cancer cell growth by reducing COX-2 and VEGF expression and cell cycle arrest. Exp Ther Med 2015;9:1709-1718.

Brown ZJ, Tsung A. Adjuvant treatment of hepatocellular carcinoma after resection. Hepat Res 2021;7:68.

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Department of General Surgery, First People's Hospital of Hangzhou Lin'an District

National Key Laboratory of Kidney Diseases

Department of Pharmacy, Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Phase Ⅰ Clinical Trials Unit, Department of Medicine for Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital

China Military Institute of Chinese Materia, Fifth Medical Center of Chinese PLA General Hospital

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