Phase II Clinical Randomized Study of the Effect of Chronomodulated Chemotherapy Followed by Concurrent IMRT Chemo-radiotherapy on the Dendritic Cells Subsets and Immunity in the Treatment of Advanced Nasopharyngeal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Dendritic cell subgroup changes of Participants
研究概览
简要总结
This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma.
详细描述
TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy.Dendritic cells (DC) play an essential role in the induction and regulation of immune responses.The effect of radiation and chemotherapy is closely related to the patients' immune function.In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed the relationship between dendritic cells subsets and clinical prognosis of patients, to provide a new method for the treatment of locally advanced nasopharyngeal carcinoma and technical support
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
- •KPS≥70 points.
- •the age of 18-70 years old, male or female.
- •no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
- •understand this study and signed informed consent
排除标准
- •Three months in the use of Chinese herbal medicine or immune modulators
- •distant metastasis.
- •who had received prior chemotherapy.
- •patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
- •pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
研究组 & 干预措施
Chrono-chemotherapy group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group
干预措施: Chrono-chemotherapy (Device)
Chrono-chemotherapy group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group
干预措施: induction Chrono-chemotherapy (Drug)
Chrono-chemotherapy group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group
干预措施: cisplatin chrono-chemotherapy (Drug)
Chrono-chemotherapy group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group
干预措施: intensity-modulated radiation therapy (Radiation)
Routine intravenous drip
control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: Routine intravenous drip (Device)
Routine intravenous drip
control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: induction Routine-chemotherapy (Drug)
Routine intravenous drip
control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: cisplatin routine-chemotherapy (Drug)
Routine intravenous drip
control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Dendritic cell subgroup changes of Participants
时间窗: termination of treatment, 3 months after treatment
By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy
次要结局
- Number of Participants with curative effect(1 year)
- Number of Participants with Adverse Events as a Measure of Safety(5 year)
研究者
Feng Jing
Head and neck cancer director, chief researcher, clinical professor
Guiyang Medical University