NCT00854971Unknown1 期
Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Colorectal Cancer
适应症
试验速览
- 阶段
- 1 期
- 发起方
- Binex
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Determine response rate
研究概览
简要总结
The purpose of this study is to determine efficacy of NKCell in colorectal cancer
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Diagnosis of histologically confirmed adenocarcinoma of the colorectal
- •ECOG performance status of 0 - 2
- •At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in physical examination
- •Adequate liver, renal, bone marrow functions as evidence by the following;
- •Absolute neutrophil count > 1.5 x 109/L; platelets > 7.5 x 109/L; Bilirubin less than 2 mg/dL ASAT and/or ALAT < 5 UNL; serum creatinine ≤ 2 ULN
- •Minimum life expectancy of 12 weeks
- •Effective contraception for both male and female subjects if the risk of conception exists
排除标准
- •Brain metastasis and/or leptomeningeal disease (known or suspected)
- •Previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment.
- •Previous oxaliplatin-based chemotherapy
- •Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy
- •HIV antibody (+), Chronic hepatitis
- •Uncontrolled infection
- •Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception
- •Clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia
- •Known hypersensitivity reaction to any of the components of the treatment.
- •Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
- •Participation in another clinical study within the 30 days before randomization
- •Significant disease which, in the investigator's opinion, would exclude the subject from the study
结局指标
主要结局
Determine response rate
时间窗: within study period
次要结局
- Determine safety of combination,time to treatment failure, overall survival time(within study period)
研究者
研究点 (2)
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