HER2 Positive CTC in Advanced Gastric Cancer

Trial Title: HER2 Positive CTC in Advanced Gastric Cancer

NCT ID: NCT01847794

Condition: HER2 Positive Advanced Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Cell Search® CTC epithelial kit
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.
Arm group label: chemotheropy

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.

Criteria for 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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Peking cancer hospital

Address:
City: Beijing
Zip: 100142
Country: China

Contact:
Last name: xiaotian zhang, MD. PhD

Phone: (86)10-88196561
Email: zhangxtxx@gmail.com

Contact backup:
Last name: jifang gong, MD. PhD

Phone: (86)10-88196561
Email: gongjifang@gmail.com

Start date: June 2013

Completion date: June 2016

Lead sponsor:
Agency: Peking University
Agency class: Other

Source: Peking University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01847794