NCT01691625已完成不适用
Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
Capital Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the quality of life
研究概览
简要总结
The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.
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
- •cytologically or histologically confirmed locally advanced esophageal carcinoma
- •Age: > 18
- •Karnofsky performance status ≥ 70
- •At least one measurable tumor lesions according to the RECIST criteria.
- •Normal functions of heart, lung, liver, kidney and bone marrow
- •Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
- •Informed consent signed
排除标准
- •Patients with metastatic disease in the central nervous system (CNS).
- •Patients who are pregnant or nursing.
- •Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
- •Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
- •coexisted morbidities that investigators believed not suitable for chemoradiation
结局指标
主要结局
the quality of life
时间窗: initial assessment, months 1, 3, 6 and 12
次要结局
- progression-free survival(1 year)
研究者
Jun Ren MD, PhD
Director,Capital Medical University (CMU)Cancer Center,
Capital Medical University
研究点 (1)
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