Rg3
A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma
Sponsor study identifier
interventional
480
1 country
5
Study Start
November 10, 2012
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
June 30, 2023
Actual (reported)Using the subject with hepatocellular carcinoma in the conventional therapy to evaluate the efficacy and safety of ginsenoside Rg3 (20mg BID) and placebo in prevention and treatment of postoperative recurrence of liver cancer,respectively
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2012
Actual (reported)October 30, 2012
Actual (reported)November 10, 2012
Actual (reported)June 30, 2023
Actual (reported)June 30, 2023
Actual (reported)recurrence-free survival
time from randomization to the first documented recurrence or death due to any reason, with subjects alive without recurrence or lost to follow-up censored at their last follow-up
1-, 2-, 3-, 5-years
overall survival
1-, 2-, 3-, 5-years
Recurrence rates at 2, 3, and 5 years
2, 3, and 5 years after randomization
Patterns of hepatocellular carcinoma recurrence
From randomization through study completion in June 2023
side effect
time from randomization until 60 days after the last dose of study drug in the treatment phase, or until initiation of new anticancer therapy, whichever occurring first
320 patients were randomly assigned to receive oral ginsenoside Rg3 (Shenyi capsule), 20 mg twice daily (40 mg daily). Screening and randomization occurred within eight weeks after curative-intent resection of hepatocellular carcinoma, and treatment began within seven days after randomization. Treatment continued until an RFS event (the first documented recurrence or death from any cause) or for a maximum of two years, whichever occurred first.
160 patients were randomly assigned to receive matching oral placebo, two capsules twice daily. Screening and randomization occurred within eight weeks after curative-intent resection of hepatocellular carcinoma, and treatment began within seven days after randomization. Treatment continued until an RFS event (the first documented recurrence or death from any cause) or for a maximum of two years, whichever occurred first.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400038, China
Tumor Hospital,Sun Yat-san University
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Tongji Hospital,Huazhong University of Science ＆ Technology
Wuhan, Hubei, 430032, China
Zhongshan hospital,Fudan University
Shanghai, 200032, China
Yue PY, Wong DY, Wu PK, Leung PY, Mak NK, Yeung HW, Liu L, Cai Z, Jiang ZH, Fan TP, Wong RN. The angiosuppressive effects of 20(R)- ginsenoside Rg3. Biochem Pharmacol. 2006 Aug 14;72(4):437-45. doi: 10.1016/j.bcp.2006.04.034. Epub 2006 May 12.
Liu TG, Huang Y, Cui DD, Huang XB, Mao SH, Ji LL, Song HB, Yi C. Inhibitory effect of ginsenoside Rg3 combined with gemcitabine on angiogenesis and growth of lung cancer in mice. BMC Cancer. 2009 Jul 23;9:250. doi: 10.1186/1471-2407-9-250.
Feng Shen, MD,PhD
Eastern Hepatobiliary Surgery Hospital
480 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2012
First Posted
October 30, 2012
Study Start
November 10, 2012
Actual (reported)Contact the study team to confirm eligibility.
Zhang Q, Kang X, Yang B, Wang J, Yang F. Antiangiogenic effect of capecitabine combined with ginsenoside Rg3 on breast cancer in mice. Cancer Biother Radiopharm. 2008 Oct;23(5):647-53. doi: 10.1089/cbr.2008.0532.
Xu TM, Cui MH, Xin Y, Gu LP, Jiang X, Su MM, Wang DD, Wang WJ. Inhibitory effect of ginsenoside Rg3 on ovarian cancer metastasis. Chin Med J (Engl). 2008 Aug 5;121(15):1394-7.
Iishi H, Tatsuta M, Baba M, Uehara H, Nakaizumi A, Shinkai K, Akedo H, Funai H, Ishiguro S, Kitagawa I. Inhibition by ginsenoside Rg3 of bombesin-enhanced peritoneal metastasis of intestinal adenocarcinomas induced by azoxymethane in Wistar rats. Clin Exp Metastasis. 1997 Nov;15(6):603-11. doi: 10.1023/a:1018491314066.
Lee JY, Jung KH, Morgan MJ, Kang YR, Lee HS, Koo GB, Hong SS, Kwon SW, Kim YS. Sensitization of TRAIL-induced cell death by 20(S)-ginsenoside Rg3 via CHOP-mediated DR5 upregulation in human hepatocellular carcinoma cells. Mol Cancer Ther. 2013 Mar;12(3):274-85. doi: 10.1158/1535-7163.MCT-12-0054. Epub 2012 Oct 10.
Zhang C, Liu L, Yu Y, Chen B, Tang C, Li X. Antitumor effects of ginsenoside Rg3 on human hepatocellular carcinoma cells. Mol Med Rep. 2012 May;5(5):1295-8. doi: 10.3892/mmr.2012.808. Epub 2012 Feb 23.
Park HM, Kim SJ, Kim JS, Kang HS. Reactive oxygen species mediated ginsenoside Rg3- and Rh2-induced apoptosis in hepatoma cells through mitochondrial signaling pathways. Food Chem Toxicol. 2012 Aug;50(8):2736-41. doi: 10.1016/j.fct.2012.05.027. Epub 2012 May 22.
Primary Completion
June 30, 2023
Actual (reported)Study Completion
June 30, 2023
Actual (reported)Last Updated
October 22, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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