Stage IV Gastric Cancer With MetastasisPhase 2SIEGNCT01964027
The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer
A Phase 2 study testing second line chemoregime for advanced gastric cancer in people with Stage IV Gastric Cancer With Metastasis, run by Anhui Medical University at 1 site in China.
Trial summary
This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IV Gastric Cancer With Metastasis
- What is being tested?
- second line chemoregime for advanced gastric cancer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Dec 2014
- 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
- Aged between 18 to 70 years
- The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy
- Measurable lesions outside the stomach
- ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1
- Expected survival time of at least 3 months
- Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred
- Blood and organ function was normal
Who cannot join
- Comorbid with other malignant tumors
- Pregnant and lactating women
- with the disease of endangering patient's safety and affecting the completion of the study
- Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure> 140mmhg, diastolic blood pressure> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction
- Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks
- Participated in clinical trials with other drugs or using other drugs during past 4 weeks
- Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oncology,The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230032
Yueyin Pan, MD, 865512922987, yueyinpan@gmail.com
Hu Liu, MD
About this study
This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.
Read the detailed description
The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, ,
The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Being tested
- second line chemoregime for advanced gastric cancer
- Keywords
- second line chemoregime, gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second line chemoregime for advanced gastric cancerDrug
Also called irinotecan plus epirubicin
Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan plus epirubicin | Experimental | Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer Receives: Drug: second line chemoregime for advanced gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS and OS
Evaluation progression-free survival (PFS) and overall survival (OS)
RECIST(Response Evaluation Criteria In Solid Tumors)1.1:
- Complete response (CR)
- Partial response (PR)
- Stable disease(SD) and progression disease(PD)
- CR + PR is efficient.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Gastric Cancer With MetastasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Yueyin, Anhui Medical University
- Investigators
- Yueyin Pan, MD, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964027
- Sponsor's protocol ID
- SIEG
- Acronym
- SIEG
- Status last verified
- Oct 2013
- First submitted
- 19 Jan 2012
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01964027
- Acronym / sponsor ID
- SIEG / SIEG
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Keywords
- second line chemoregime, gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Oct 2013 (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.
This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.
Detailed description
The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, ,
The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan plus epirubicin | Experimental | Drug: second line chemoregime for advanced gastric cancerIrinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18 to 70 years
- The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy
- Measurable lesions outside the stomach
- ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1
- Expected survival time of at least 3 months
Key exclusion criteria (7 listed)
- Comorbid with other malignant tumors
- Pregnant and lactating women
- with the disease of endangering patient's safety and affecting the completion of the study
- Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure> 140mmhg, diastolic blood pressure> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction
- Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks
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 |
|---|---|---|
| second line chemoregime for advanced gastric cancerAlso: irinotecan plus epirubicinIrinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer | Drug | Irinotecan plus epirubicin |
Primary outcome
PFS and OS
Time frame: 2 years
Evaluation progression-free survival (PFS) and overall survival (OS) RECIST(Response Evaluation Criteria In Solid Tumors)1.1: 1. Complete response (CR) 2. Partial response (PR) 3. Stable disease(SD) and progression disease(PD) 4. CR + PR is efficient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
Related trials for Stage IV Gastric Cancer With Metastasis
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Active, not recruitingPhase 2
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1/2
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
STOMACH NEOPLASM, Gastric Cancer
RecruitingPhase 3
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
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.
Yueyin Pan, MD principal investigator
The First Affiliated Hospital of Anhui Medical University
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 second line chemoregime for advanced gastric cancer in people with Stage IV Gastric Cancer With Metastasis, run by Anhui Medical University 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 7 inclusion and 7 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 17 Oct 2013. 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 Yueyin Pan, MD (865512922987, yueyinpan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS and OS (time frame: 2 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 17 Oct 2013.