NCT01717066

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

October 26, 2012

Last Update Submit

March 30, 2016

Conditions

Stage I Hepatocellular CarcinomaStage II Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinomaginsenoside Rg3

Outcome Measures

Primary Outcomes (1)

  • time to recurrence

    the interval between the initial hepatectomy and date of diagnosis of recurrent HCC

    1,2,3 years

Secondary Outcomes (1)

  • overall survival

    1,2,3 years

Other Outcomes (1)

  • side effect

    eighteen months

Study Arms (2)

the ginsenoside Rg3

EXPERIMENTAL

320 HCCs,the ginsenoside Rg3 capsule,4-8 weeks after surgery, will be taken, 2 capsules, BID, 8 weeks as one cycle, continue taking it until the tumor recurs or until the end date of the study for patients without recurrence

Drug: the ginsenoside Rg3

the placebo

PLACEBO COMPARATOR

160 HCCs as control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group

Drug: Placebo

Interventions

the ginsenoside Rg3DRUG
Also known as: Shen Yi capsule
the ginsenoside Rg3
PlaceboDRUG
the placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old,male and female
  • Mainly based on the criteria for liver cancer TNM stage I and II (edition 7) and BCLC stage A, the following needs to be satisfied:
  • individual tumor larger than or equal to 2 cm and smaller than or equal to 10 cm in the maximum diameter
  • multiple tumors with no more than three tumors
  • No macroscopic tumor embolus
  • ECOG performance state is 0-1
  • Child-Pugh grade is A
  • The clinical review confirms the absence of recurrence within 8 weeks before the enrollment
  • Sign the informed consent

You may not qualify if:

  • Pregnant and breast-feeding women
  • Patients with severe diseases in the brain, heart,lungs, kidneys and hematological system
  • Patients who have received other anti-tumor therapies before the surgery (including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy)
  • DDS chemotherapy pump placed in the portal vein during the surgery
  • Patients who are participating in other drug trials
  • Patients known or suspected to be allergic to ginsenoside, with a history of allergy to biological preparations, allergic constitution or currently in an allergic state;
  • With active severe clinical infection
  • Epilepsy episode which needs drug therapy
  • With a history of allotransplantation;
  • With a previous history of tumor in other systems, but except for:
  • Carcinoma in situ of cervix
  • Basal cell carcinoma after treatment,Superficial bladder cancer (Ta, Tis and T1
  • Any cancer after curative treatment no less than three years ago
  • Patients with signs or a history of bleeding diathesis
  • Patients currently receiving kidney dialysis
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Tumor Hospital,Sun Yat-san University

Guangzhou, Guangdong, 510060, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Tongji Hospital,Huazhong University of Science ＆ Technology

Wuhan, Hubei, 430032, China

Location

Zhongshan hospital,Fudan University

Shanghai, 200032, China

Location

Related Publications (8)

  • 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.

    PMID: 16793023BACKGROUND

  • 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.

    PMID: 19624862BACKGROUND

  • 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.

    PMID: 18999937BACKGROUND

  • 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.

    PMID: 18959116BACKGROUND

  • 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.

    PMID: 9344044BACKGROUND

  • 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.

    PMID: 23053497BACKGROUND

  • 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.

    PMID: 22366885BACKGROUND

  • 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.

    PMID: 22634290BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Feng Shen, MD,PhD

    Eastern Hepatobiliary Surgery Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

October 26, 2012

First Posted

October 30, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(5)