NCT00842491已完成2 期
A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer
Peking University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe.
详细描述
Endostar, a recombinant human endostatin, has shown its antitumor ability in combination in NSCLC and breast cancer. But to gastric cancer, few clinical data has been reported. However, bevacizumab, an angiogenesis inhibitor was shown effective in combination with chemotherapy in advanced gastric cancer in some phase II study. So in this study, we want to explore whether endostar is also effective and safe in advanced gastric cancer. Response predictive factor is expected to be identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed informed consent
- •Age 18 to 70 years old
- •Histologically confirmed gastric adenocarcinoma
- •Unresectable recurrent or metastatic disease
- •Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
- •Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
- •Measurable disease according to the RECIST criteria
- •Karnofsky performance status ≥60
- •Life expectancy of ≥2 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
排除标准
- •Brain metastasis (known or suspected)
- •Previous systemic therapy for metastatic gastric cancer
- •Inability to take oral medication
- •Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
- •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
- •Any investigational agent within the past 28 days
- •Other previous malignancy within 5 year, except non-melanoma skin cancer
- •Previous adjuvant therapy with capecitabine+platinum,
- •Pre-existing neuropathy>grade 1
- •Legal incapacity
研究组 & 干预措施
endostar+chemotherapy
Experimental
干预措施: endostar, cisplatin, capecitabine (Drug)
endostar+chemotherapy
Experimental
干预措施: capecitabine (Drug)
endostar+chemotherapy
Experimental
干预措施: cisplatin (Drug)
结局指标
主要结局
Progression free survival
时间窗: 3 year
次要结局
- Disease control rate(1 year)
- adverse evens(5 year)
- Overall survival(5 year)
- The alteration of relative regional blood volume of the tumor(3weeks)
- Tumor response rate(1 year)
研究者
Shen Lin
pro.
Peking University
研究点 (1)
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