NCT01232062已完成不适用
Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic 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 46 人开始时间: 2010年8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
- 46
- 试验地点
- 1
- 主要终点
- response to chemotherapy
研究概览
简要总结
To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic 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 HDC and cellular therapy.HDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed by two cycles HDC, plus low-dose Oral Cyclophosphamide.
- PET-CT scans were done on each patients at baseline and after chemotherapy. 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
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（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;
- •Metastatic tumor measured by PET-CT scan is at least 1cm;
- •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
- •Do not finish twice PET-CT scan;
- •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
response to chemotherapy
时间窗: 4months
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
次要结局
- clinical benefit response(six months to one year)
- Time to disease progression(six months to one year)
- survival rates(one-year)
研究者
Jun Ren
Director
Peking University Cancer Hospital & Institute
研究点 (1)
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