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

Primary Purpose

HER2 Positive Advanced Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cell Search® CTC epithelial kit
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HER2 Positive Advanced Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking cancer hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotheropy

Arm Description

Outcomes

Primary Outcome Measures

HER2 positive CTC

Secondary Outcome Measures

clinical significance of HER 2 positive CTC

Full Information

First Posted
April 29, 2013
Last Updated
May 2, 2013
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT01847794
Brief Title
HER2 Positive CTC in Advanced Gastric Cancer
Acronym
AGC-HER2CTC
Official Title
Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Positive Advanced Gastric Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chemotheropy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cell Search® CTC epithelial kit
Intervention 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.
Primary Outcome Measure Information:
Title
HER2 positive CTC
Time Frame
2 months
Secondary Outcome Measure Information:
Title
clinical significance of HER 2 positive CTC
Time Frame
2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 <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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lin shen, MD. PhD
Phone
(86)10-88196175
Email
lin100@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD. PhD
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaotian zhang, MD. PhD
Phone
(86)10-88196561
Email
zhangxtxx@gmail.com
First Name & Middle Initial & Last Name & Degree
jifang gong, MD. PhD
Phone
(86)10-88196561
Email
gongjifang@gmail.com

12. IPD Sharing Statement

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HER2 Positive CTC in Advanced Gastric Cancer

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