Stage I Hepatocellular CarcinomaRg3NCT01717066
the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma
A study testing the ginsenoside Rg3 in people with Stage I Hepatocellular Carcinoma and Stage II Hepatocellular Carcinoma, run by Shen Feng at 5 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma
- What is being tested?
- the ginsenoside Rg3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 5 sitesChina
- Study dates
- 10 Nov 2012to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-75 years.
- Histopathologically confirmed hepatocellular carcinoma (HCC), primarily based on TNM stage I or II (7th edition) and BCLC stage A criteria, with the following tumor characteristics:
- A solitary tumor measuring ≥2 cm and ≤10 cm in maximum diameter; or
- Multiple tumors numbering no more than three, with each tumor measuring ≤5 cm in maximum diameter.
- Curative-intent resection meeting all of the following requirements:
- Complete removal of all macroscopic tumor nodules.
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- Microscopically tumor-free resection margins.
- No macroscopic vascular invasion or extrahepatic distant metastasis.
- Absence of residual disease confirmed by imaging and serum tumor markers before randomization.
- ECOG performance status of 0 or 1.
- Child-Pugh class A liver function.
- Screening and randomization within eight weeks after surgery.
- Full recovery from surgery and, if applicable, postoperative adjuvant transarterial chemoembolization (TACE).
- Patients who received postoperative adjuvant TACE before randomization because of high-risk factors for recurrence were eligible, provided that they had fully recovered and met all other eligibility criteria.
- Written informed consent provided before any study-specific procedures.
Who cannot join
- Pregnancy or breastfeeding.
- Severe diseases affecting the brain, heart, lungs, kidneys, or hematological system.
- Receipt of anticancer treatment before surgery, including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy, or other anticancer treatment.
- Placement of a drug delivery system chemotherapy pump in the portal vein during surgery.
- Receipt of postoperative adjuvant anticancer therapy, including systemic chemotherapy, targeted therapy, radiotherapy, or traditional Chinese medicines with documented anticancer activity, except for adjuvant TACE performed before randomization because of high-risk factors for recurrence.
- Participation in another drug trial.
Show all 20Show fewer
- Known or suspected allergy to ginsenosides, a history of allergy to biological preparations, an allergic predisposition, or an ongoing allergic reaction.
- Active severe clinical infection.
- Seizures requiring drug treatment.
- A history of allogeneic transplantation.
- A history of malignancy in another organ system, except for:
- Carcinoma in situ of the cervix.
- Treated basal cell carcinoma or superficial bladder cancer (Ta, Tis, or T1).
- Other malignancies treated with curative intent at least three years previously.
- Signs or a history of bleeding diathesis.
- Current renal dialysis.
- Gastrointestinal bleeding within the previous 30 days, severe gastroesophageal varices with red signs, or a history of gastroesophageal variceal hemorrhage.
- Recurrent HCC.
- Inability to take oral medication.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400038
Tumor Hospital,Sun Yat-san University
Guangzhou, Guangdong, 510060
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Zhongshan hospital,Fudan University
Shanghai, 200032
Tongji Hospital,Huazhong University of Science ＆ Technology
Wuhan, Hubei, 430032
About this study
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
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
Read the detailed description
- Study design A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial conducted at six tertiary centers in China: Eastern Hepatobiliary Surgery Hospital, Zhongshan Hospital, Tongji Hospital, Southwest Hospital, Sun Yat-sen University Cancer Center, and the First Affiliated Hospital of Harbin Medical University.
- Study population Eligible patients aged 18-75 years who underwent curative-intent resection of histopathologically confirmed hepatocellular carcinoma, with no evidence of residual disease within eight weeks after surgery. Patients were required to have Child-Pugh class A liver function and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Full eligibility criteria are provided in the Eligibility section.
- Treatment groups Ginsenoside Rg3 group: standard postoperative care plus oral ginsenoside Rg3. Placebo group: standard postoperative care plus matching oral placebo. Additional adjuvant anticancer therapies, including transarterial chemoembolization, interferon, targeted therapy, immune checkpoint inhibitors, and anticancer herbal medicines, were prohibited after randomization and before recurrence.
- Randomization and masking Patients were randomly assigned in a 2:1 ratio to receive ginsenoside Rg3 or placebo through an interactive web-response system. Randomization used permuted blocks of six and was stratified by sex, tumor size (≤3 cm versus >3 cm), tumor number (solitary versus multiple), and microvascular invasion status. The allocation sequence was concealed from enrollment personnel. Patients, investigators, and trial staff were blinded to treatment assignment.
- Dose, administration, and treatment duration Treatment began within seven days after randomization. Ginsenoside Rg3 group: oral ginsenoside Rg3, 20 mg twice daily (40 mg daily). Placebo group: matching placebo, two capsules twice daily. In both groups, 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.
- Screening, follow-up, and safety monitoring
Screening and randomization occurred within eight weeks after surgery. Baseline assessments were completed within three days before randomization.
The first follow-up visit occurred at treatment week eight. Subsequent visits were scheduled every two months during the first two years after randomization, every four months during years three and four, and every six months thereafter. Patients without recurrence were followed for at least five years.
Each scheduled visit included serum alpha-fetoprotein testing, liver function tests, and abdominal ultrasonography. Contrast-enhanced abdominal magnetic resonance imaging and chest computed tomography were performed every four months during the first four years after randomization and every six months thereafter, or earlier if recurrence was suspected.
Adverse events were monitored at each two-month drug-dispensing visit and scheduled follow-up visit. Adverse events were collected from randomization until 60 days after the last dose of study treatment in the treatment phase or initiation of new anticancer therapy, whichever occurred first. All serious adverse events were followed until resolution or stabilization.
- Being tested
- the ginsenoside Rg3, Placebo
- Keywords
- Hepatocellular Carcinoma, ginsenoside Rg3
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the ginsenoside Rg3Drug
Also called Shen Yi capsule
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| the ginsenoside Rg3 | Experimental | 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. Receives: Drug: the ginsenoside Rg3 |
| the placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-, 2-, 3-, 5-years
Secondary outcomes (3)
overall survival
time from randomization to death from any cause, with subjects alive or lost to follow-up censored at their last follow-up
Measured: 1-, 2-, 3-, 5-years
Recurrence rates at 2, 3, and 5 years
Cumulative incidence of hepatocellular carcinoma recurrence at 2, 3, and 5 years after randomization, with death without recurrence treated as a competing event.
Measured: 2, 3, and 5 years after randomization
Patterns of hepatocellular carcinoma recurrence
Recurrence patterns characterized by timing (early recurrence within two years after randomization or late recurrence beyond two years), location (intrahepatic, extrahepatic, or concurrent intrahepatic and extrahepatic recurrence), and morphological features, including the number, size, and anatomical sites of recurrent tumors.
Measured: From randomization through study completion in June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study start10 Nov 2012
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stage I Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shen Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Shanghai Zhongshan Hospital, Sun Yat-Sen University Cancer Center, First Affiliated Hospital of Harbin Medical University, Southwest Hospital, Third Military Medical University
- Responsible party
- Sponsor-investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Feng Shen, MD,PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717066
- Sponsor's protocol ID
- EHBH-RCT-2011-002
- Acronym
- Rg3
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2012
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16793023Liu 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.
PubMed 19624862Zhang 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.
PubMed 18999937Xu 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.
PubMed 18959116Iishi 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.
PubMed 9344044Lee 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.
PubMed 23053497Zhang 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.
PubMed 22366885Park 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.
PubMed 22634290
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01717066
- Acronym / sponsor ID
- Rg3 / EHBH-RCT-2011-002
- Keywords
- Hepatocellular Carcinoma, ginsenoside Rg3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Shen FengUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Shanghai Zhongshan Hospital, Sun Yat-Sen University Cancer Center, First Affiliated Hospital of Harbin Medical University, Southwest Hospital, Third Military Medical University
- Study start
- 10 Nov 2012 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Study design A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial conducted at six tertiary centers in China: Eastern Hepatobiliary Surgery Hospital, Zhongshan Hospital, Tongji Hospital, Southwest Hospital, Sun Yat-sen University Cancer Center, and the First Affiliated Hospital of Harbin Medical University.
- Study population Eligible patients aged 18-75 years who underwent curative-intent resection of histopathologically confirmed hepatocellular carcinoma, with no evidence of residual disease within eight weeks after surgery. Patients were required to have Child-Pugh class A liver function and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Full eligibility criteria are provided in the Eligibility section.
- Treatment groups Ginsenoside Rg3 group: standard postoperative care plus oral ginsenoside Rg3. Placebo group: standard postoperative care plus matching oral placebo. Additional adjuvant anticancer therapies, including transarterial chemoembolization, interferon, targeted therapy, immune checkpoint inhibitors, and anticancer herbal medicines, were prohibited after randomization and before recurrence.
- Randomization and masking Patients were randomly assigned in a 2:1 ratio to receive ginsenoside Rg3 or placebo through an interactive web-response system. Randomization used permuted blocks of six and was stratified by sex, tumor size (≤3 cm versus >3 cm), tumor number (solitary versus multiple), and microvascular invasion status. The allocation sequence was concealed from enrollment personnel. Patients, investigators, and trial staff were blinded to treatment assignment.
- Dose, administration, and treatment duration Treatment began within seven days after randomization. Ginsenoside Rg3 group: oral ginsenoside Rg3, 20 mg twice daily (40 mg daily). Placebo group: matching placebo, two capsules twice daily. In both groups, 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.
- Screening, follow-up, and safety monitoring
Screening and randomization occurred within eight weeks after surgery. Baseline assessments were completed within three days before randomization.
The first follow-up visit occurred at treatment week eight. Subsequent visits were scheduled every two months during the first two years after randomization, every four months during years three and four, and every six months thereafter. Patients without recurrence were followed for at least five years.
Each scheduled visit included serum alpha-fetoprotein testing, liver function tests, and abdominal ultrasonography. Contrast-enhanced abdominal magnetic resonance imaging and chest computed tomography were performed every four months during the first four years after randomization and every six months thereafter, or earlier if recurrence was suspected.
Adverse events were monitored at each two-month drug-dispensing visit and scheduled follow-up visit. Adverse events were collected from randomization until 60 days after the last dose of study treatment in the treatment phase or initiation of new anticancer therapy, whichever occurred first. All serious adverse events were followed until resolution or stabilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the ginsenoside Rg3 | Experimental | Drug: the ginsenoside Rg3320 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. |
| the placebo | Placebo comparator | Drug: Placebo160 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female patients aged 18-75 years.
- Histopathologically confirmed hepatocellular carcinoma (HCC), primarily based on TNM stage I or II (7th edition) and BCLC stage A criteria, with the following tumor characteristics:
- Curative-intent resection meeting all of the following requirements:
- ECOG performance status of 0 or 1.
- Child-Pugh class A liver function.
Key exclusion criteria (20 listed)
- Pregnancy or breastfeeding.
- Severe diseases affecting the brain, heart, lungs, kidneys, or hematological system.
- Receipt of anticancer treatment before surgery, including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy, or other anticancer treatment.
- Placement of a drug delivery system chemotherapy pump in the portal vein during surgery.
- Receipt of postoperative adjuvant anticancer therapy, including systemic chemotherapy, targeted therapy, radiotherapy, or traditional Chinese medicines with documented anticancer activity, except for adjuvant TACE performed before randomization because of high-risk factors for recurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the ginsenoside Rg3Also: Shen Yi capsule | Drug | the ginsenoside Rg3 |
| Placebo | Drug | the placebo |
Primary outcome
recurrence-free survival
Time frame: 1-, 2-, 3-, 5-years
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
3 secondary outcomes
overall survival
Time frame: 1-, 2-, 3-, 5-years
Recurrence rates at 2, 3, and 5 years
Time frame: 2, 3, and 5 years after randomization
Patterns of hepatocellular carcinoma recurrence
Time frame: From randomization through study completion in June 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 16793023Yue 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.
- Background: PubMed 19624862Liu 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.
- Background: PubMed 18999937Zhang 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.
- Background: PubMed 18959116Xu 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.
- Background: PubMed 9344044Iishi 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.
- Background: PubMed 23053497Lee 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.
- Background: PubMed 22366885Zhang 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.
- Background: PubMed 22634290Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Shen, MD,PhD principal investigator
Eastern Hepatobiliary Surgery Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the ginsenoside Rg3 in people with Stage I Hepatocellular Carcinoma and Stage II Hepatocellular Carcinoma, run by Shen Feng at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free survival (time frame: 1-, 2-, 3-, 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717066, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.