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


N/A
18 Years
N/A
Not Enrolling
Both
HER2 Positive Advanced Gastric Cancer

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Trial Information

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


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
- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

HER2 positive CTC

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Lin Shen, MD. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University

Authority:

China: Food and Drug Administration

Study ID:

CGOG5002

NCT ID:

NCT01847794

Start Date:

June 2013

Completion Date:

June 2016

Related Keywords:

  • HER2 Positive Advanced Gastric Cancer
  • Stomach Neoplasms

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