A Randomized, Open Label, Controlled Study About Endostar Continued Pumping or Injecting Into Vein Combining With Gemcitabine-Carboplatin Versus Gemcitabine-Carboplatin Alone to Treat Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 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 with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.
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-Carboplatin (GC)chemotherapy in patients with NSCLC,and seeking for more effective injection.
Methods:
In this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): Experimental: Endostar -Continued Pumping into+Gemcitabine-Carboplatin(GC),Active Comparator: Endostar -injecting into +Gemcitabine-Carboplatin(GC),Active Comparator: Gemcitabine-Carboplatin(GC),
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 70 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 III/IV NSCLC;
- •Age of 18-70years; 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+GC
Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin
干预措施: Gemcitabine,Carboplatin,Endostar (Drug)
Endostar -injecting into +GC
Endostar that is injecting into vein with Gemcitabine -Carboplatin
干预措施: Gemcitabine(G) Carboplatin(C) Endostar (Drug)
GC
Gemcitabine -Carboplatin
干预措施: Gemcitabine(G) Carboplatin(C) (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: two years
次要结局
- adverse reaction(two years)
- Overall survival (OS)(two years)
- Time to progression(TTP)(two years)
- Clinical benefit rate (CBR)(two years)
- The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.(two years)
研究者
Jianhua Chen
professer
Hunan Province Tumor Hospital