跳至主要内容
临床试验/NCT06393140
NCT06393140招募中不适用

The Study on the Mechanism of Radiotherapy-elicited Immune Response

Fudan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Genetic signature of patients who had received neoadjuvant or definitive radiation therapy

研究概览

简要总结

Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. Data from many laboratories indicate that local radiation produces systemic, immune-mediated anti¬tumour and, potentially, antimetastatic effects. Additionally, the combination of local radiotherapy and immune-modulation can augment local tumour control and cause distant (abscopal) antitumour effects through increased tumour-antigen release and antigen-presenting cell (APC) cross-presentation, improved dendritic-cell (DC) function, and enhanced T cell priming. The generation of an effective antitumor immune response requires the presentation of tumor antigens to naïve CD8+ cells in tumor-draining lymph nodes (TDLN) . Tumor-draining lymph nodes, however, are often subject to the immunosuppressive activity of tumor-derived factors, such as cytokines and other bioactive molecules from tumor cells and their associated leukocytes in the primary tumor site that contribute to the overriding of effective rejection mechanisms. Thus, in TDLN a T cell tolerance rather than a T cell activation often occurs, thereby preventing immune attack and facilitating local tumor progression.

详细描述

In this study, the investigators collect clinical and biological evidence to interpret the impact of radiotherapy on tumor regression and immunity, and identify key molecular features and immune landscape patterns to characterize patients sensitive/resistant to radiotherapy; and define the dynamic changes occurring in TME and lymph node after radiotherapy.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • new diagnosis locoregional esophageal cancer;
  • pathologic diagnosis is squamous carcinoma;
  • Patients had received either neoadjuvant or definitive radiotherapy
  • tumor and lymph node tissue can be collected and can be conducted with single cell RNA (scRNA)-sequencing and other sequencings.

排除标准

  • Pregnant or lactating women.
  • Unable or rejection to receive radiotherapy or unable to comply with study requirements or follow-up schedule.
  • Inability to provide informed consent.

结局指标

主要结局

Genetic signature of patients who had received neoadjuvant or definitive radiation therapy

时间窗: 4-year

Detailed mechanism of radiation-activated immunity under single-cell sequencing.gene mutations, copy number variants.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kuai Le Zhao, MD

professor

Fudan University

研究点 (1)

Loading locations...

相似试验

The Study on the Mechanism of Radiotherapy-elicited... | 临床试验