NCT02780778Unknown2 期
Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •≥ 18 and ≤ 75 years of age
- •Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
- •EGFR mutation testing negative of sensitive mutations
- •At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
- •Have failed for 1 lines of chemotherapy
- •ECOG performance scale 0 -
- •Life expectancy of more than 3 months.
- •Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
- •More than 4 weeks after operation or radiotherapy
- •More than 4 weeks for cytotoxic agents
- •Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min,
- •Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •Received more than one kind of chemotherapy regimens
- •NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy
- •Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
- •Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- •Any factors that influence the usage of oral administration
- •The center of the tumor invaded local large blood vessels
- •Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
- •Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
- •Less than 4 weeks from the last clinical trial
研究组 & 干预措施
Treatment group
Experimental
Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w
干预措施: Apatinib (Drug)
Treatment group
Experimental
Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w
干预措施: Docetaxel (Drug)
结局指标
主要结局
progression-free survival
时间窗: 1 Day
次要结局
- objective remission rate(1 Day)
- disease control rate(1 Day)
- Quality of life score(1 Day)
研究者
研究点 (1)
Loading locations...
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