NCT01839539Unknown2 期
Phase Ⅱ Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Stage Ⅲ Colorectal Cancer
Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).
详细描述
60 patients with stage Ⅲ CRC, who had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, and got complete response (CR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of age;
- •CRC with histological diagnose, and had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy and got complete response (CR) with imaging;
- •Patients who have a life expectancy of at least 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
- •The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);
- •The ECG results were normal, and the liver and kidney were functional.
排除标准
- •Patients who had distant metastases;
- •Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- •Patients who were pregnant or lactating;
- •ECOG perform status ≥ 2;
- •Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 5 years
次要结局
- Overall survival (OS)(5 years)
- Quality of life (QOL)(5 years)
- Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell)(1 month)
研究者
Weiliang Sun
Investigator
Guangxi Medical University
研究点 (1)
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