NCT01757366

UnknownPhase 2

Safety and Efficacy of Ginsenoside Rg3 in Combination With F...

Hebei Tumor Hospital Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

HBTH102

Study Type

interventional

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

December 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2016

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2016

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 100 participants
Study completion date: December 2016
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 21, 2012
Actual (reported)
First Posted
December 28, 2012
Actual (reported)
Primary Completion
January 2016
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 1, 2014
Status Verified: December 2012
Last Update Submitted: 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

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;

Sponsors & Collaborators

Hebei Tumor Hospital
Otherlead

Study Sites (1)

Hebei Tumor Hospital

Shijiazhuang, Hebei, 050011, China

RECRUITING

Baoen ShanCONTACT13803343508 15931166600@126.com

Wei LiuPRINCIPAL INVESTIGATOR

MeSH Terms

Interventions

ginsenoside Rg3

Study Officials

Wei Liu
Hebei Tumor Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Baoen Shan

CONTACT

15931166600 15931166600@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 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2016

Estimated (date passed)

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Phase 2Unknown

Active Comparator

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2016

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 1, 2014

Record last verified: 2012-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01757366
Data provider: ClinicalTrials.gov
Source updated: 2014-04-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:08 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

experimental

Active Comparator

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations