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

NCT ID: NCT01757366

Last Updated: 2014-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experimental

Ginsenoside Rg3 plus First-line Chemotherapy

Group Type EXPERIMENTAL

Ginsenoside Rg3 plus First-line Chemotherapy

Intervention Type DRUG

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

Active Comparator

First-line Chemotherapy

Group Type ACTIVE_COMPARATOR

First-line Chemotherapy

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Liu

Role: PRINCIPAL_INVESTIGATOR

Hebei Tumor Hospital

Locations

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Hebei Tumor Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Baoen Shan

Role: CONTACT

15931166600

Facility Contacts

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Baoen Shan

Role: primary

13803343508

Other Identifiers

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HBTH102

Identifier Type: -

Identifier Source: org_study_id

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