Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).
详细描述
Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.
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
- •Histologically or cytologically diagnosed NSCLC;
- •primary treatment,inoperable stage IIIB/IV NSCLC;
- •Age of 18-75years; Gender Not Required;
- •Adequate hematologic, renal, and hepatic function ,Specific index as follows:
- •liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;
- •ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
- •The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
- •No history of serious drug allergy;
- •Informed consent should be obtained before treatment.
排除标准
- •Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
- •Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
- •Serious complications and investigator consider it is unsuited enrolling;
- •Pregnant or lactating women;
- •Allergic to research drug;
- •participating in other experimental trials and receive the treatment in four weeks;
- •The position that is for observing curative effect have a radiotherapy.
研究组 & 干预措施
Endostar -Continued Pumping into+GP
Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin
干预措施: Endostar -Continued Pumping into+GP (Drug)
Endostar -injecting into +GP
Endostar that is injecting into vein with Gemcitabine -Cisplatin
干预措施: Endostar -injecting into +GP (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: two years
次要结局
- Overall survival (OS)(two years)
- Clinical benefit rate (CBR)(two years)
- Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability(two years)
研究者
Liyan Xu
Chief of Medical Oncology Department
Beijing Chest Hospital