Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tumor Regression Rate
研究概览
简要总结
This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The pathology proved to be non small cell lung cancer (must be histologically).
- •At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;
- •The patients were evaluated by imaging, laboratory examination and other examination;
- •Without chemotherapy or anti angiogenic therapy;
- •There can be measured lesions
- •Informed consent.
排除标准
- •Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.
- •Severe infection.
- •Severe heart disease.Neuropsychiatric disorders, which is not easy to control.
- •Severe diabetes.
- •There is obvious bleeding tendency.
- •The 5 years history of other tumors
研究组 & 干预措施
Endostatin plus NP
drug:Endostatins Intravenous drip， 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
干预措施: Cisplatin (Drug)
Endostatin plus NP
drug:Endostatins Intravenous drip， 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
干预措施: Endostatin (Drug)
Endostatin plus NP
drug:Endostatins Intravenous drip， 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
干预措施: Vinorelbine (Drug)
NP neoadjuvant chemotherapy
drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
干预措施: Vinorelbine (Drug)
NP neoadjuvant chemotherapy
drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin，75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
干预措施: Cisplatin (Drug)
结局指标
主要结局
Tumor Regression Rate
时间窗: 3 months
Target lesion size reduction ratio
次要结局
- Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.(5 years)
- Overall Survival(5 years)
- Clinical Benefit Rate(3 months)