An Exploratory Study of Low-dose Apatinib Combined With S-1 in Patients With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.
详细描述
Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.
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
- •Pathologically confirmed Non-small cell lung cancer
- •Patients with extracranial measurable lesions
- •Patients with NSCLC failed for standard treatments
- •Eastern Cooperative Oncology Group performance status score: 0~2 and life expectancy of more than 3 months
- •Major organs functioning properly
- •Compliance is good and agreed to cooperate with the survival of follow-up
- •Informed consent
排除标准
- •Contraindications for investigational agents
- •Patients with clinical symptoms of brain metastases or meningeal metastasis
- •Tumor invade big vessels or close to big vessels
- •Uncontrolled hypertension
- •Abnormal coagulation (INR>1.5 or Prothrombin Time>ULN+4, or Activated Partial Thromboplastin Time>1.5 ULN), bleeding tendency or receiving coagulation therapy
- •Hemoptysis, more than 2.5ml daily
- •Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
- •Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
- •Received big surgery, had bone fracture or ulcer in 4 weeks.
- •Urine protein≥++, or urine protein in 24 hours≥1.0g
研究组 & 干预措施
Apatinib & S-1
Apatinib Mesylate tablet combined with S-1 Capsules Apatinib Mesylate tablet 250mg once daily combined with S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules) 40mg~60mg twice daily by mouth, d1-14, repeated every 3 weeks.
干预措施: Apatinib Mesylate tablet combined with S-1 capsules (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: 2 years
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
次要结局
- Overall Survival(OS)(2 years)
- Objective response rate(ORR)(2 years)
- Disease Control Rate(DCR)(2 years)
- Adverse Events(AEs)(2 years)