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

Hebei Tumor Hospital

Status and phase: Unknown; Phase 2

Conditions: Self Efficacy

Treatments: Drug: First-line Chemotherapy; Drug: Ginsenoside Rg3 plus First-line Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01757366

HBTH102

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

experimental

Experimental group

Description:

Ginsenoside Rg3 plus First-line Chemotherapy

Treatment:

Drug: Ginsenoside Rg3 plus First-line Chemotherapy

Active Comparator

Active Comparator group

Description:

First-line Chemotherapy

Treatment:

Drug: First-line Chemotherapy