NCT01847794Unknown不适用
Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer
Peking University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HER2 positive CTC
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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 \3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
排除标准
- •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
结局指标
主要结局
HER2 positive CTC
时间窗: 2 months
次要结局
- clinical significance of HER 2 positive CTC(2years)
研究者
Shen Lin
Director of GI oncology
Peking University
研究点 (1)
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