NCT01305980Unknown2 期
Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluating Tumor Response Rate
研究概览
简要总结
The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.
详细描述
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy will be evaluated every 3 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18years or over
- •Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions
- •Life expectancy >/= 5 months
- •Not available to any of resectable surgery or radiotherapy
- •Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by
- •Absolute neutrophil count >/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
- •Total bilirubin < 2.0 mg/dL
- •Aspartate Aminotransferase and/or Aspartate Aminotransferase < 5 x Upper Limit Normal
- •creatinine < 2 x Upper Limit Normal
- •ECOG status 0 to 2
- •Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago
- •Patients or their legal representatives who have signed the informed consent form.
排除标准
- •Have inflammatory bowel diseases
- •Have severe diarrhea or ileus
- •Previous total colectomy
- •Have ileostomy
- •Known brain or spinal cord metastases
- •Patients who have received chemotherapy within the previous 4 weeks
- •Patients who have received radiotherapy related tp colorectal cancer within 4weeks
- •Patients who have participated in other clinical study within the previous 4weeks
- •Pregnancy or lactation period
- •Human Immunodeficiency Virus antibody (+)
- •Have active infection or serious concomitant systemic disorder incompatible with the study
- •Clinically hypertension or diabetes mellitus not well controlled with medication
- •Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
- •Presence or history of malignancy other than colorectal cancer within 5years
- •Have severe Neurologic or psychological disorder
- •Patients who have history of allergy with this investigational drug(SB injection)
- •Obvious cognitive or physical impairment that would prevent participation
结局指标
主要结局
Evaluating Tumor Response Rate
时间窗: 4 months
次要结局
- Pain Scores on the Visual Analog Scale(4 months)
- evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale(4 months)
- Determine duration of response rate by measuring time to progression(4 months)
研究者
研究点 (2)
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