NCT01757366

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 1, 2014

Status Verified

December 1, 2012

Enrollment Period

3.1 years

First QC Date

December 21, 2012

Last Update Submit

March 30, 2014

Conditions

Self Efficacy

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    1 years

Secondary Outcomes (2)

  • Objective Response Rate (ORR)

    1 year

  • Overall Survival (OS)

    3 year

Study Arms (2)

experimental

EXPERIMENTAL

Ginsenoside Rg3 plus First-line Chemotherapy

Drug: Ginsenoside Rg3 plus First-line Chemotherapy

Active Comparator

ACTIVE COMPARATOR

First-line Chemotherapy

Drug: First-line Chemotherapy

Interventions

Ginsenoside Rg3 plus First-line ChemotherapyDRUG

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

experimental
First-line ChemotherapyDRUG

XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression

Active Comparator

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Tumor Hospital

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Interventions

ginsenoside Rg3

Study Officials

  • Wei Liu

    Hebei Tumor Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baoen Shan

CONTACT

1593116660015931166600@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2012

First Posted

December 28, 2012

Study Start

December 1, 2012

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

April 1, 2014

Record last verified: 2012-12

Locations

CN(1)