NCT01691664Unknown不适用
Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Capital Medical University1 个研究点 分布在 1 个国家目标入组 40 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
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal 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
- 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 esophageal carcinoma
- •Tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease
- •Prior en bloc resection, with curative intent, of all known tumor
- •No metastatic disease
- •Age: > 18
- •Karnofsky performance status ≥ 70
- •At least 3 weeks since prior surgery
- •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
- •All patients must be evaluated by a radiation oncologist prior to enrollment to ensure patient is appropriate for radiotherapy
- •Informed consent signed
排除标准
- •Patients with metastatic disease.
- •Patients who are pregnant or nursing.
- •Patients with poor bone marrow, liver and kidney functions, which would make radiation therapy intolerable
- •Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
结局指标
主要结局
Disease free survival
时间窗: 4 years
次要结局
- quality of life(Initial assessment → months 1,3,6 and 12)
研究者
Jun Ren MD, PhD
Director, Capital Medical University Cancer Center
Capital Medical University
研究点 (1)
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