Additional TR study on "Phase 2 study of Trastuzumab Deruxtecan in the neoadjuvant treatment for patients with HER2 positive gastric and gastroesophageal junction adenocarcinoma" (T-DXd_NAC TR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 37
- 主要终点
- Analysis of cancer-related genetic abnormalities
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients enrolled in the "Phase 2 study of Trastuzumab Deruxtecan in the neoadjuvant treatment for patients with HER2 positive gastric and gastroesophageal junction adenocarcinoma" who have consented for the study will be included.
排除标准
- 未提供
结局指标
主要结局
Analysis of cancer-related genetic abnormalities
DNA and ctDNA extracted from tumor tissues and blood will be analyzed for somatic gene abnormalities (whole genome sequencing) using a next-generation sequencing (NGS), and we will attempt to identify biomarkers based on the genetic abnormalities.
Immunohistochemical staining analysis and proteomic analysis
Immunohistochemistry (IHC) of tumor formalin-fixed paraffin-embedded (FFPE) tissue will be performed using antibodies to various immune cell markers to identify immune cell-related biomarkers. In addition, IHC using anti-HER2 antibody was performed. IHC using anti-HER2 antibody will also be performed to identify biomarkers related to HER2 levels. Furthermore, we will conduct comprehensive proteomic analysis of proteins extracted from tumor tissues by mass spectrometry, and try to identify biomarkers based on the amount of proteins.
mRNA analysis
Using RNA extracted from tumor tissues, RNA sequencing will be performed to analyze gene expression in tumor tissues and attempt to identify biomarkers from the viewpoint of gene expression.
Single-cell RNA-sequence (scRNAseq)
We will conduct comprehensive gene expression analysis of all cell types in the tumor and analyze the characteristic gene expression profiles in each cell type to identify biomarkers.
次要结局
未报告次要终点