Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer

Phase 2

• Conditions: Self Efficacy
• Interventions: Drug: Ginsenoside Rg3 plus First-line Chemotherapy; Drug: First-line Chemotherapy

• Registration Number: NCT01757366
• Lead Sponsor: Hebei Tumor Hospital

Brief Summary

Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-28
• Last Update Submitted: 2014-03-30
• Last Update Posted: 2014-04-01
• Primary Completion: 2016-01
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Signed informed consent form
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
3. Histologically or cytologically confirmed gastric cancer;
4. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
5. Life expectancy of at least 3 months;

Exclusion Criteria

1. Received any prior treatment including Ginsenoside Rg3;
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	Ginsenoside Rg3 plus First-line Chemotherapy	Ginsenoside Rg3 plus First-line Chemotherapy
Active Comparator	First-line Chemotherapy	First-line Chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	1 years

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	1 year
Overall Survival (OS)	3 year

Trial Locations

Locations (1)

Hebei Tumor Hospital; 🇨🇳 Shijiazhuang, Hebei, China