HER2 Positive CTC in Advanced Gastric Cancer

NCT01847794 | Unknown

• 1 other identifier: CGOG5002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2 Positive Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• HER2 positive CTC

  2 months

Secondary Outcomes (1)

• clinical significance of HER 2 positive CTC

  2years

Study Arms (1)

chemotheropy

EXPERIMENTAL

Device: Cell Search® CTC epithelial kit

Interventions

Cell Search® CTC epithelial kit DEVICE

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.

chemotheropy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking cancer hospital

Beijing, Beijing Municipality, 100142, China

Location

Study Officials

• Lin Shen, MD. PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lin shen, MD. PhD

CONTACT

(86)10-88196175; lin100@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of GI oncology

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 7, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

CN (1)