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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030210361

Enrollment

Registered

2021-10-02

Start date

2021-10-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2 positive gastric and gastroesophageal junction adenocarcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactAkihito Kawazoe

National Cancer Center Hospital East

T-DXd_NAC_core@east.ncc.go.jp+81-4-7133-1111

Outcome results