Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Disease Attributes

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Liver Extracts

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

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

the ginsenoside Rg3

Placebo

Feng Shen, MD,PhD

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

1. Randomized, double-blind, multi-center, placebo-controlled, parallel-group;
2. Subject population: patients undergone radical resection of hepatocellular carcinoma;
3. 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

the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma

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

the adverse reactions of the application of ginsenoside Rg3,for example:severe dry pharynx

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

the interval between the date of the initial hepatectomy and the date of death or last follow-up

Huazhong University of Science and Technology

Shanghai Zhongshan Hospital

Sun Yat-sen University

First Affiliated Hospital of Harbin Medical University

First Affiliated Hospital of Fujian Medical University

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Herbal and Botanical

Amino Acids

Angiogenesis Inhibitors

Chlorotrianisene

Endothelial Growth Factors

Mitogens

Tyrosine Kinase Inhibitors

Growth Inhibitors

Ginseng

Tyrosine

Anti-angiogenic targeted drug + Rg3 + TACE

A tyrosine kinase inhibitor inhibits vascular endothelial growth factor (VEGF) receptors 1-3, showed efficacy in hepatocellular carcinoma

Anti-angiogenic Targeted Drugs

An active ingredient extracted from ginseng leachate, which can restrain angiogenesis and reduce the expression of programmed cell death ligand 1 (PD-L1) on the tumor cell surface and block the binding of programmed cell death 1 (PD-1) and PD-L1

A specific type of chemoembolization that blocks the hepatic artery to treat liver cancer

TACE

Feng Shen, MD

The aim of this study is to compare the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with the anti-angiogenic targeted drugs and ginsenoside Rg3 versus TACE alone in patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage B/C hepatocellular carcinoma (HCC), who has normal liver function and no extrahepatic metastasis.

TACE is widely used in patients with unresectable HCC, which has been proved to significantly improve the survival time by the results from some randomized controlled studies and meta-analyses. However, due to the different blood supply characteristics and biological heterogeneity in HCC nodules, the therapeutic effect of TACE is limited, and which is still considered as a non-radical treatment. Furthermore, vascular embolization by TACE may result in hypoxia in tumor tissue, which will induce increased secretion of angiogenic factors such as vascular endothelial growth factor (VEGF) and tumor angiogenesis, promote proliferation of residual tumor cells, and enhance tumor invasive and metastasis. Accordingly, the effectiveness of TACE is still unsatisfying as a single treatment for HCC.

Both anti-angiogenic targeted drugs and ginsenoside Rg3 have showed synergistic effect with TACE in patients with unresectable HCC. The purpose of this trial is to evaluate the efficacy and safety of the combination of anti-angiogenic targeted drugs and ginsenoside Rg3 plus TACE comparing to TACE alone in patients with unresectable HCC.

Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma

A Multicentre Randomized Controlled Study of Anti-angiogenic Targeted Drugs Combined With Ginsenoside Rg3 to Improve the Efficacy of Transcatheter Arterial Chemoembolization (TACE) in the Treatment of Unresectable Hepatocellular Carcinoma

The proportion of patients whose tumor has changed from unresectable to resectable after Intervention

the time from randomization to documented progression

the time from randomization to TACE untreatable progression

The proportion of patients whose tumor volume has decreased to a predetermined value

The time period from the randomization of the patient to the death event due to any reason

The severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard the severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard the severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma	NCT01717066	Stage I Hepatoc... Stage II Hepato...	the ginsenoside... Placebo	18 Years - 75 Years	Eastern Hepatobiliary Surgery Hospital
Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma	NCT04523467	Hepatocellular ...	Anti-angiogenic... Ginsenoside Rg3 TACE	18 Years - 75 Years	Eastern Hepatobiliary Surgery Hospital
Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma	NCT04523467	Hepatocellular ...	Anti-angiogenic... Ginsenoside Rg3 TACE	18 Years - 75 Years	Eastern Hepatobiliary Surgery Hospital
Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma	NCT04523467	Hepatocellular ...	Anti-angiogenic... Ginsenoside Rg3 TACE	18 Years - 75 Years	Eastern Hepatobiliary Surgery Hospital

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