NCT01099124已完成不适用
Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse events incidence,including severe adverse events incidence
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years old;
- •Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
- •No contraindication for chemotherapy;
- •ECOG performance scale 0-2;
- •No history of anti-angiogenesis therapy;
- •Patients are voluntary to participate and sigh the informed contents.
排除标准
- •Concurrent use of other anti-cancer agents;
- •Allergic history to M2ES and biological agents;
- •Pregnant or breast-feeding women;
- •With other malignancy;
- •With severe cardiopulmonary disease;
- •Uncontrolled brain metastasis patients;
- •Other conditions that are regarded for exclusion by the trialists.
研究组 & 干预措施
M2ES combined with chemotherapy
Experimental
干预措施: M2ES (Drug)
结局指标
主要结局
Adverse events incidence,including severe adverse events incidence
时间窗: one year
次要结局
- Tumor response rate and disease controlled rate(one year)
研究者
研究点 (1)
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