跳至主要内容
临床试验/CTRI/2024/07/070266
CTRI/2024/07/070266尚未招募不适用

The expression of HER2 low in gastric and gastroesophageal junction adenocarcinoma

G B Pant institute of post graduate medical education and research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Percentage of cases showing expression of HER2 low expression in Gastric and Gastroesophageal adenocarcinoma.

研究概览

简要总结

Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma is the fifth most common malignancy and the third leading cause of cancer-related mortality worldwide. Adenocarcinoma is the most common type of gastric cancer. These cancers have poor prognosis and surgery is the only potentially curative approach. Neoadjuvant or adjuvant chemotherapy should be combined with surgery in locally advanced cases. 15-20% of gastric and GEJ carcinoma is associated with HER2 overexpression.

Human epidermal growth factor receptor 2 (HER2) is a member of epidermal growth factor receptor family which has tyrosine kinase activity and plays a role in cell proliferation and survival.Recently, trastuzumab deruxtecan (T-DXd)-an antibody drug conjugate (ADC) consisting of an anti-HER2 antibody with a cytotoxic topoisomerase I inhibitor demonstrated superior efficacy to standard cytotoxic chemotherapies in patients with HER2-positive G/GEJ adenocarcinoma and showed some efficacy in HER2 low carcinoma.

This study aims to assess the prevalence of HER2- low (HER2 1+ or 2+ without amplification) in gastroesophageal junction and gastric adenocarcinoma, and to evaluate its association with clinical and histopathological features.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Histopathological diagnosis of gastric or gastroesophageal junction adenocarcinoma.

排除标准

  • Patients on neoadjuvant therapy, recurrent gastric/gastroesophageal junction adenocarcinoma and inadequate biopsy material.

结局指标

主要结局

Percentage of cases showing expression of HER2 low expression in Gastric and Gastroesophageal adenocarcinoma.

时间窗: Baseline

次要结局

  • 1.Association of HER2 low expression with clinical parameters i.e age, sex & duration of symptoms.(2.Association of HER2 low expression with histopathological features i.e tumor grade, tumor stage, histological subtype, H. pylori status.)

研究者

发起方
G B Pant institute of post graduate medical education and research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rajendra Prasad Shah

G B Pant institute of post graduate medical education and research

研究点 (1)

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