HER2 Positive CTC in Advanced Gastric Cancer (AGC-HER2CTC)
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100142
- Peking Cancer Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:chemotheropy
|
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
HER2 positive CTC
大体时间:2 months
|
2 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
clinical significance of HER 2 positive CTC
大体时间:2years
|
2years
|
合作者和调查者
调查人员
- 首席研究员:Lin Shen, MD. PhD、Peking University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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