the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma (Rg3)
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ClinicalTrials.gov Identifier: NCT01717066 |
Recruitment Status
:
Completed
First Posted
: October 30, 2012
Last Update Posted
: March 31, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stage I Hepatocellular Carcinoma Stage II Hepatocellular Carcinoma | Drug: the ginsenoside Rg3 Drug: Placebo | Not Applicable |
- Randomized, double-blind, multi-center, placebo-controlled, parallel-group;
- Subject population: patients undergone radical resection of hepatocellular carcinoma;
- Active drug group:
Ginsenoside Rg3 group: general treatment + ginsenoside Rg3 Control group (placebo group): general treatment + placebo 4.Method of group assignment: 5research centers, central-block-stratified randomization, a ratio of active drug group to control group: 2:1 5.Dose and mode of administration: Ginsenoside Rg3 group: ginsenoside Rg3 20mg BID, two months as one cycle, continue until recurrence occurs Placebo Group: placebo, 2 capsules, BID, continue until recurrence occurs 6.Study period: Screening phase: screening for enrollment within 8 weeks after the radical resection Follow up: review every 2-3 months following the surgery Post-trial investigation: within 28 days after the trial is ended or the recurrence occurs
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 480 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: the ginsenoside Rg3
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
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Drug: the ginsenoside Rg3
Other Name: Shen Yi capsule
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Placebo Comparator: the placebo
160 HCCs as control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group
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Drug: Placebo |
- time to recurrence [ Time Frame: 1,2,3 years ]the interval between the initial hepatectomy and date of diagnosis of recurrent HCC
- overall survival [ Time Frame: 1,2,3 years ]the interval between the date of the initial hepatectomy and the date of death or last follow-up
- side effect [ Time Frame: eighteen months ]the adverse reactions of the application of ginsenoside Rg3,for example:severe dry pharynx

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-75 years old,male and female
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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
Exclusion Criteria:
- 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;
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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
- A history of bleeding in the gastrointestinal tract within 30 days, or severe gastroesophageal varices with red signs; with a history of gastroesophageal variceal hemorrhage
- Recurrent HCC
- Patients unable to take drug orally
- Patients inappropriate to participate in the trial upon the investigator's judgment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717066
China, Fujian | |
The First Affiliated Hospital of Fujian Medical University | |
Fuzhou, Fujian, China, 350005 | |
China, Guangdong | |
Tumor Hospital,Sun Yat-san University | |
Guangzhou, Guangdong, China, 510060 | |
China, Heilongjiang | |
The First Affiliated Hospital of Harbin Medical University | |
Harbin, Heilongjiang, China, 150001 | |
China, Hubei | |
Tongji Hospital,Huazhong University of Science & Technology | |
Wuhan, Hubei, China, 430032 | |
China | |
Zhongshan hospital,Fudan University | |
Shanghai, China, 200032 |
Principal Investigator: | Feng Shen, MD,PhD | Eastern Hepatobiliary Surgery Hospital |
Publications:
Responsible Party: | ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital |
ClinicalTrials.gov Identifier: | NCT01717066 History of Changes |
Other Study ID Numbers: |
EHBH-RCT-2011-002 |
First Posted: | October 30, 2012 Key Record Dates |
Last Update Posted: | March 31, 2016 |
Last Verified: | March 2016 |
Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
Hepatocellular Carcinoma ginsenoside Rg3 |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Hepatocellular Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Disease Attributes Pathologic Processes Ginsenoside Rg3 Antineoplastic Agents, Phytogenic Antineoplastic Agents |