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

Self Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01757366
• Other study ID #: HBTH102
• Status: Recruiting
• Phase: Phase 2
• First received: December 21, 2012
• Last updated: March 30, 2014
• Start date: December 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2012
• Source: Hebei Tumor Hospital
• Contact: Baoen Shan
• Phone: 15931166600
• Email: 15931166600[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Self Efficacy

Intervention

Drug:
• Ginsenoside Rg3 plus First-line Chemotherapy
Ginsenoside Rg3 20mg 2/day po,patients will receive Ginsenoside Rg3 until progression XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression
• First-line Chemotherapy
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression

Locations

Country	Name	City	State
China	Hebei Tumor Hospital	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		1 years	Yes
Secondary	Objective Response Rate (ORR)		1 year	Yes
Secondary	Overall Survival (OS)		3 year	Yes