NCT01305967Unknown2 期
Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Overall Best Response Rate
研究概览
简要总结
The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.
详细描述
All eligible patients will receive SB injection therapy for 4 cycles (14~21 days for each cycle). SB injection treatment could be continue after completion of therapy cycles until 6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be evaluated every two cycles.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-70 years
- •Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer
- •Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
- •Patients with measurable lesions
- •Eatern Cooperative Oncolgy Group status 0 to
- •Life expectancy >/= 5 months
- •Patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by
- •Absolute neutrophil count >/= 1.5 x 10^9/L, Platelet count >/= 100 x 10^9/L
- •Total bilirubin </= upper limit of normal
- •Aspartate Aminotransferase and/or Alanine Aminotransferase </= 2 x upeer limit of normal
- •creatinine </= 1.5 x upeer limit of normal
- •Patients who have signed the informed consent form.
排除标准
- •Female volunteers admitted to the study must be using a reliable means of contraception
- •Received radiation therapy within 6 weeks before randomization
- •Known brain or spinal cord metastases
- •Have acute infection
- •Have active infection or serious concomitant systemic disorder incompatible with the study
- •Presence or history of malignancy other than Non-Small Cell Lung Cancer
- •Have severe neurologic or psychological disorder
- •Patients who have to receive other chemo-radiotherapy or immunotherapy
- •Patients who have received chemotherapy within the previous 30 days
- •Patients who are candidates for combined modality treatment.
- •Patients who have participated in a clinical study within the previous 30 days
结局指标
主要结局
Overall Best Response Rate
时间窗: 2.5 months
次要结局
- Determine duration of response rate by measuring time to progression(2.5 months)
- Pain Scores on the Visual Analog Scale(2.5months)
- Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale(2.5months)
研究者
研究点 (6)
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