HER2 Positive CTC in Advanced Gastric Cancer (AGC-HER2CTC)
Primary Purpose
HER2 Positive Advanced Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cell Search® CTC epithelial kit
Sponsored by
About this trial
This is an interventional basic science trial for HER2 Positive Advanced Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Having signed informed consent
- 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:
- Previous systemic therapy for metastatic gastric cancer
- 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
Sites / Locations
- Peking cancer hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chemotheropy
Arm Description
Outcomes
Primary Outcome Measures
HER2 positive CTC
Secondary Outcome Measures
clinical significance of HER 2 positive CTC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847794
Brief Title
HER2 Positive CTC in Advanced Gastric Cancer
Acronym
AGC-HER2CTC
Official Title
Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
5. Study Description
Brief Summary
To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.
Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Positive Advanced Gastric Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chemotheropy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cell Search® CTC epithelial kit
Intervention Description
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.
Primary Outcome Measure Information:
Title
HER2 positive CTC
Time Frame
2 months
Secondary Outcome Measure Information:
Title
clinical significance of HER 2 positive CTC
Time Frame
2years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having signed informed consent
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:
Previous systemic therapy for metastatic gastric cancer
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lin shen, MD. PhD
Phone
(86)10-88196175
Email
lin100@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD. PhD
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaotian zhang, MD. PhD
Phone
(86)10-88196561
Email
zhangxtxx@gmail.com
First Name & Middle Initial & Last Name & Degree
jifang gong, MD. PhD
Phone
(86)10-88196561
Email
gongjifang@gmail.com
12. IPD Sharing Statement
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HER2 Positive CTC in Advanced Gastric Cancer
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