NCT01395056已完成不适用
Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2011年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients
详细描述
- Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
- All the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide .
- The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
- Estimate time to progression, survival rates and clinical benefit response on patients.
- Find biomarkers associated with drug response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Failure to anthracycline and/or taxol chemotherapy;
- •metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
- •Metastatic tumor can not be removed through surgery procedure;
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Normal cardiac, hepatic, renal and bone marrow functions;
- •Life expectancy ≥3 months.
排除标准
- •Central nervous system metastases;
- •Serious or uncontrolled concurrent medical illness;
- •History of other malignancies;
- •Having been enrolled in some other clinal trials within a month;
结局指标
主要结局
progression-free survival
时间窗: six months to two year
progression-free survivalis measured from the date therapy is initiated to the date of documented disease progression or death
次要结局
- clinical benefit response and overall survival(six months to two year)
研究者
Jun Ren
Director of the Medical Oncology
Peking University Cancer Hospital & Institute
研究点 (1)
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