Self EfficacyPhase 2NCT01757366
Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
A Phase 2 study testing Ginsenoside Rg3 plus First-line Chemotherapy and First-line Chemotherapy in people with Self Efficacy, run by Hebei Tumor Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Self Efficacy
- What is being tested?
- Ginsenoside Rg3 plus First-line Chemotherapy and First-line Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Tumor Hospital
Shijiazhuang, Hebei, 050011
Baoen Shan, 13803343508, 15931166600@126.com
Wei Liu
About this study
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.
- Conditions
- Self Efficacy
- Being tested
- Ginsenoside Rg3 plus First-line Chemotherapy, First-line Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Ginsenoside Rg3 plus First-line Chemotherapy Receives: Drug: Ginsenoside Rg3 plus First-line Chemotherapy |
| Active Comparator | Active comparator | First-line Chemotherapy Receives: Drug: First-line Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 1 years
Secondary outcomes (2)
Objective Response Rate (ORR)
Measured: 1 year
Overall Survival (OS)
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Liu, Principal investigator, Hebei Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757366
- Sponsor's protocol ID
- HBTH102
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2012
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01757366
- Acronym / sponsor ID
- HBTH102
- Conditions
- Self Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Tumor HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: Ginsenoside Rg3 plus First-line ChemotherapyGinsenoside Rg3 plus First-line Chemotherapy |
| Active Comparator | Active comparator | Drug: First-line ChemotherapyFirst-line Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginsenoside Rg3 plus First-line ChemotherapyGinsenoside 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 | Drug | experimental |
| First-line ChemotherapyXELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression | Drug | Active Comparator |
Primary outcome
Progression-free survival (PFS)
Time frame: 1 years
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: 1 year
Overall Survival (OS)
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Liu principal investigator
Hebei Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginsenoside Rg3 plus First-line Chemotherapy and First-line Chemotherapy in people with Self Efficacy, run by Hebei Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baoen Shan (15931166600, 15931166600@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.