Additional TR study on "Phase 2 study of Trastuzumab Deruxtecan in the neoadjuvant treatment for patients with HER2 positive gastric and gastroesophageal junction adenocarcinoma"

JRCT ID: jRCT1030210361

Registered date:02/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HER2 positive gastric and gastroesophageal junction adenocarcinoma
• Date of first enrollment: 02/10/2021
• Target sample size: 37
• Study type: Observational

Outcome(s)

Primary Outcome

In this study, we will attempt to identify biomarkers for efficacy by conducting the following analyses.
1) 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.
2) 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.
3) 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.
4) 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 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.
• Exclude criteria: None

Related Information

• Primary Sponsor: Shitara Kohei
• Secondary Sponsor: Takahari Daisuke,Kawazoe Akihito,Daiichi Sankyo Co., Ltd.