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

Primary Purpose

Self Efficacy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ginsenoside Rg3 plus First-line Chemotherapy
First-line Chemotherapy
Sponsored by
Hebei Tumor Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Efficacy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hebei Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental

Active Comparator

Arm Description

Ginsenoside Rg3 plus First-line Chemotherapy

First-line Chemotherapy

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Objective Response Rate (ORR)
Overall Survival (OS)

Full Information

First Posted
December 21, 2012
Last Updated
March 30, 2014
Sponsor
Hebei Tumor Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01757366
Brief Title
Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
Official Title
Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Tumor Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
Ginsenoside Rg3 plus First-line Chemotherapy
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
First-line Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Ginsenoside Rg3 plus First-line Chemotherapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
First-line Chemotherapy
Intervention Description
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
1 year
Title
Overall Survival (OS)
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; Histologically or cytologically confirmed gastric cancer; At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ) Life expectancy of at least 3 months; Exclusion Criteria: Received any prior treatment including Ginsenoside Rg3; Active or uncontrolled infection; Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial; Pregnant or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baoen Shan
Phone
15931166600
Email
15931166600@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Liu
Organizational Affiliation
Hebei Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Tumor Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoen Shan
Phone
13803343508
Email
15931166600@126.com
First Name & Middle Initial & Last Name & Degree
Wei Liu

12. IPD Sharing Statement

Learn more about this trial

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

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