HER2 Positive CTC in Advanced Gastric Cancer
HER2 Positive Advanced Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Study Phase
Study Design
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Name: Cell Search® CTC epithelial kit
Type: Device
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Peking cancer hospital
Beijing, Beijing, China
Status: Not yet recruiting
Contact: xiaotian zhang, MD. PhD - (86)10-88196561 - zhangxtxx@gmail.com
Start Date
June 2013
Completion Date
June 2016
Peking University
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page