臨床研究等提出・公開システム

Date of registration	Oct. 02, 2021
Last modified on	Oct. 02, 2021
Trial ID	jRCT1030210361

Scientific Title	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)
Public Title	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)

Contact for Scientific Queries	Name	Shitara Kohei
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha, Kashiwa, Chiba
	Telephone	+81-4-7133-1111
	E-mail	T-DXd_NAC_core@east.ncc.go.jp
Contact for Public Queries	Name	Kawazoe Akihito
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha, Kashiwa, Chiba
	Telephone	+81-4-7133-1111
	E-mail	T-DXd_NAC_core@east.ncc.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 02, 2021
Target sample size		37
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion Criteria	None
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		HER2 positive gastric and gastroesophageal junction adenocarcinoma
Primary Outcome(s)		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.

Primary Sponsor	National Cancer Center Hospital East

Source of Monetary Support / Secondary Sponsor	Daiichi Sankyo Co., Ltd.
Secondary Sponsor	Applicable

Secondary Sponsor

Name of Certified Review Board	National Cancer Center IRB
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail	NCC_IRBoffice@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	June. 17, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None