Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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chemotheropy
Cell Search® CTC epithelial kit
Collect peripheral blood sample of 50 gastric cancer patients pre-chemotherapy and post two cycles of chemotherapy(response evaluation).
Blood samples will be transferred to central lab to detect HER2 positive CTCs by Cellsearch epithelial kit.
Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.
Interventions
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Cell Search® CTC epithelial kit
Collect peripheral blood sample of 50 gastric cancer patients pre-chemotherapy and post two cycles of chemotherapy(response evaluation).
Blood samples will be transferred to central lab to detect HER2 positive CTCs by Cellsearch epithelial kit.
Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.
Eligibility Criteria
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Inclusion Criteria
* Age≥ 18 years old
* HER2 overexpression confirmed by IHC or ISH (IHC 3+,or IHC2+/ISH+)
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
Exclusion Criteria
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Legal incapacity
18 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Shen Lin
Director of GI oncology
Principal Investigators
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Lin Shen, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University
Locations
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Peking cancer hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CGOG5002
Identifier Type: -
Identifier Source: org_study_id
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