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

Liver Cirrhosis

Fibrosis

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

Ultrasound Tomography

Aya Kamaya

This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.

OUTLINE:

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

B-mode Ultrasound Imaging in Detecting Early Liver Cancer

Quantitative Ultrasound Spectroscopy to Early HCC

The Mid-band fit is related to the intensity of the returned ultrasound signal at different frequencies has been shown to change with tissue morphology.

Spectral intercept (SI) is mostly related to the number scatterers and their density in the tissue. Changes in the SI have been demonstrated to occur due to different pathologies and result from treatments that change the structure of the tissue being imaged.

Summarized as the maximum and/or average value over the lesion of interest (using a region of interest selection) and the liver image as a whole.

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
B-mode Ultrasound Imaging in Detecting Early Liver Cancer	NCT02774161	Cirrhosis Early Hepatocel... Fibrosis Stage I Hepatoc... Stage II Hepato...	Ultrasound Tomo...	18 Years -	Stanford University
B-mode Ultrasound Imaging in Detecting Early Liver Cancer	NCT02774161	Cirrhosis Early Hepatocel... Fibrosis Stage I Hepatoc... Stage II Hepato...	Ultrasound Tomo...	18 Years -	Stanford University

Spots Global Cancer Trial Database for stage i hepatocellular carcinoma