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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Self Efficacy

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

1 years

Safety Issue:

Yes

Principal Investigator

Wei Liu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hebei Tumor Hospital

Authority:

China: Food and Drug Administration

Study ID:

HBTH102

NCT ID:

NCT01757366

Start Date:

December 2012

Completion Date:

December 2016

Related Keywords:

  • Self Efficacy
  • Stomach Neoplasms

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