HER2 Positive CTC in Advanced Gastric Cancer (AGC-HER2CTC)

May 2, 2013 updated by: Shen Lin, Peking University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chemotheropy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HER2 positive CTC
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical significance of HER 2 positive CTC
Time Frame: 2years
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Lin Shen, MD. PhD, Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGOG5002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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