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Status unknownNCT01757366Updated Apr 1, 2014

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

A Phase 2 interventional study of Ginsenoside Rg3 plus First-line Chemotherapy and First-line Chemotherapy in Self Efficacy, sponsored by Hebei Tumor Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-04-01.

Sponsored by Hebei Tumor Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Self Efficacy

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In context

Stomach Neoplasms

2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's planned enrollment of 100 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Hebei Tumor Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • DrugGinsenoside 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

  • DrugFirst-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

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What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 1 years

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 1 year

  2. Overall Survival (OS)

    Time frame: 3 year

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Study locations

1 of 1 sites recruiting
  • Hebei Tumor Hospital
    Shijiazhuang, Hebei 050011, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01757366
Lead sponsor
Hebei Tumor Hospital
Responsible party
Sponsor
First posted
Dec 28, 2012
Start date
Dec 2012
Primary completion
Jan 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Apr 1, 2014

Study contacts

Baoen Shan
Contact
15931166600@126.com
15931166600
Wei Liu
principal investigator · Hebei Tumor Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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