HER2 Positive CTC in Advanced Gastric Cancer

HER2 Positive Advanced Gastric Cancer Clinical Trial

— AGC-HER2CTC  

Official title:

Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01847794
• Other study ID #: CGOG5002
• Status: Not yet recruiting
• Phase: N/A
• First received: April 29, 2013
• Last updated: May 2, 2013
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: May 2013
• Source: Peking University
• Contact: lin shen, MD. PhD
• Phone: (86)10-88196175
• Email: lin100[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• HER2 Positive Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Peking cancer hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HER2 positive CTC		2 months	No
Secondary	clinical significance of HER 2 positive CTC		2years	No