NCT03117946已完成不适用
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 5
- 主要终点
- tumor antigen specific T-cell responses
研究概览
简要总结
The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Histologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer) OR histologically confirmed Head and neck cancer
- •Patient candidate to a first-line concomitant radiochemotherapy
- •Written informed consent
排除标准
- •Sequential radiochemotherapy, exclusive radiotherapy, or stereotactic radiotherapy
- •History of adjuvant radiochemotherapy for cancer treatment
- •Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
- •HIV, hepatitis C or B virus
- •Patients with any medical or psychiatric condition or disease,
- •Patients under guardianship, curatorship or under the protection of justice.
研究组 & 干预措施
Biological samples
Experimental
Blood samples will be collected at baseline, at J15/J20 after RTCT initiation, and then 1 month, 3 months and 12 months after the end of RTCT treatment, and at disease progression if applicable.
Tumor tissues will be collected if available.
干预措施: Biological samples (Other)
结局指标
主要结局
tumor antigen specific T-cell responses
时间窗: up to 12 months after the end of radiochemotherapy
tumor antigen specific T-cell responses
次要结局
- monitoring of immune checkpoints, immune cell death, immune suppressive cells and T-cell polarisation(up to 12 months after the end of radiochemotherapy)
- Progression free survival(date of first progression of the disease (within 2 year after the initiation of the treatment)])
- Quality of life related to health measured by EORTC-QLQC30(from the inclusion to patient death, up to 1 year)
- overall survival(date of death from any cause (within 2 years after the initiation of the treatment))
研究者
研究点 (5)
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