Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Karnofsky Performance Status
研究概览
简要总结
The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.
详细描述
There are three arms controlled group. First group receives standard medical theraphy (radiotherapy or chemoradiation), second group who receives autologous dendritic cell (Auto-DC), and third group receives the combination of allogenic-dendritic cell-secretomes (Allo-DC Secretome) and continued with autologous dendritic cell (Auto-DC).
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer
- •Patients who have partial response or stable disease or progressive disease after performed standard therapy (radiology or chemoradiation) based on RECIST
- •Did not take traditional medicine in the last 2 months.
- •Patients can understand the nature of the study and willing to sign informed consent
- •Patients who received standard medical (radiology or chemoradiation) up to one additional therapy in the last 1 month.
排除标准
- •Patients who are pregnant, planning to pregnant, or breastfeeding
- •Patients assessed to require chemoradiation during this study
- •Patients who get complete score after undergo standard therapy (radiology or chemoradiation) based on the RECIST
- •Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis
- •Patients who have creatinin clearance result <40 ml/min, bilirubin serum >1.5x above normal, SGPT-SGOT >5x above normal
- •Patients on immunosuppressive medications, such as corticosteroids
- •Patients who undergo Major thoracic or abdominal operation
- •Patients on high medical risk condition due to uncontrolled infection
- •Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiency virus (HIV)
- •Patients who have concurrent congestive heart failure history and other heart disease
- •Patients who have health conditions assessed by the doctor in charge cannot be included in this clinical trial
- •Patients who refuse or did not participate in part or all of the research process
研究组 & 干预措施
Placebo (Aqua Pro-Injection)
Subject will given 2 times injection of Aqua Pro-Injection via intramuscular (interval 2 days).
干预措施: Placebo (Aqua Pro-Injection) (Other)
Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)
Subject will given injection of Aqua Pro-Injection via intramuscular, two days after followed by Auto-DC via intramuscular.
干预措施: Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) (Biological)
Combination of Auto DC and Allo-DC-Secretome
Subject will given injection of Allo-DC-Secretome via intramuscular, two days after followed by Auto-DC via intramuscular.
干预措施: Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy) (Biological)
结局指标
主要结局
Karnofsky Performance Status
时间窗: 3 months after therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
Karnofsky Performance Status
时间窗: Before therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
Karnofsky Performance Status
时间窗: 1 week after therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
Karnofsky Performance Status
时间窗: 1 month after therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
次要结局
未报告次要终点