A Study of the Tumor Microenvironment Affecting the Efficacy of Immunotherapy for Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Immunotherapy efficacy
研究概览
简要总结
This study is a retrospective study of clinical specimens. The study subjects were patients with esophageal cancer who received immunotherapy. Tumor tissue specimens surgically removed from patients before treatment will be collected primarily. In situ immunohistochemistry and multicolor immunofluorescence will be performed. We hypothesize that there are differences in lipid metabolism-related proteins in tumor tissues and immune cells in the preexisting tumor microenvironment in patients with esophageal cancer prior to immunotherapy, and that there is a link between such differences and the efficacy of immunotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Esophageal cancer patients receiving immunotherapy
- •Radical esophagectomy for esophageal cancer at our institution prior to receiving immunotherapy
- •Age greater than or equal to 18 years and less than or equal to 75 years old Imaging to assess patient efficacy after cycle 2 immunotherapy (CR/PR, SD/PD according to recist 1.1)
- •Pathology Tumor tissue available
排除标准
- •Clinical and pathologic information not available
- •Combined history of other malignant tumors
- •Unavailability of surgically resected tissue
- •Preoperative neoadjuvant therapy
- •Radical esophagectomy for esophageal cancer not performed prior to immunotherapy
结局指标
主要结局
Immunotherapy efficacy
时间窗: 2018-2022
Imaging to assess patient efficacy after cycle 2 immunotherapy (CR/PR, SD/PD according to Recist 1.1)
CR、PR、SD、PD
时间窗: 2018-2022
CR：All target lesions disappear and the short diameter of all pathologic lymph nodes (both target and non-target nodes) must be reduced to \<10 mm. PR：At least 30% reduction in the sum of target lesion diameters from baseline levels SD：A relative increase in diameter sum of at least 20% (or the baseline value if the baseline measurement is minimal), referenced to the minimum of the sum of the diameters of all measured target lesions throughout the course of the experimental study; in addition to this, an increase in the absolute value of diameter sum of at least 5 mm must be met (the presence of one or more new lesions is also considered to be disease progression). Translated with www.DeepL.com/Translator (free version) PD：The target lesion did not decrease to the level of PR, nor did it increase to the level of PD, and in between, the minimum value of the sum of the diameters can be used as a reference for the study.
次要结局
未报告次要终点
研究者
Yongshun Chen
professor
Renmin Hospital of Wuhan University