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临床试验/NCT04850716
NCT04850716招募中不适用

An Observational Study of Relationship Between Standard Treatment Efficacy and The Tumor Microenvironment in Advanced Gastric Cancer

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2021年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
89
试验地点
1
主要终点
Progression-Free Survival (PFS)

研究概览

简要总结

Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. In advanced gastric cancer, systemic treatment based on chemotherapy drugs, targeted drugs, and immune checkpoint inhibitors remains the main regimens. Among current standard treatment regimens, though HER2-positive and MSI-H/dMMR statuses indicate the treatment efficacy of trastuzumab and immune checkpoint inhibitors, there is still lack of robust biomarkers for predicting treatment efficacy. Tumor microenvironment as pivotal components of solid tumor, significantly influences therapeutic response and clinical outcome. The study is a multi-center, observational study to evaluate the relationship between standard treatment efficacy and the tumor microenvironment in advanced gastric cancer. In addition, the study comprehensively evaluated the landscape of the tumor microenvironment characteristics of gastric cancer, and aimed at establishing robust biomarkers for predicting prognosis and treatment efficacy to finetune treatment strategies.

详细描述

Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. In advanced gastric cancer, systemic treatment based on chemotherapy drugs, targeted drugs, and immune checkpoint inhibitors remains the main regimens. Among current standard treatment regimens, though HER2-positive and MSI-H/dMMR statuses indicate the treatment efficacy of trastuzumab and immune checkpoint inhibitors, there is still lack of robust biomarkers for predicting treatment efficacy. Tumor microenvironment as pivotal components of solid tumor, significantly influences therapeutic response and clinical outcome. The study is a multi-center, observational study to evaluate the relationship between standard treatment efficacy and the tumor microenvironment in advanced gastric cancer. In addition, the study comprehensively evaluated the landscape of the tumor microenvironment characteristics of gastric cancer, and aimed at establishing robust biomarkers for predicting prognosis and treatment efficacy to finetune treatment strategies. Eligible subjects were selected according to the inclusion criteria and exclusion criteria. After successful screening, the patients were treated following the clinical guidelines and the actual conditions. The residual tissue samples of the primary tumor or metastatic foci were collected to conduct the tumor microenvironment detection analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically or cytologically confirmed advanced gastric cancer.
  • Willing to receive anti-tumor drug treatment.
  • Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
  • At least one measurable lesion or non-measurable but evaluable as defined by RECIST 1.1.

排除标准

  • Human epidermal growth factor receptor 2 (HER2) is positive, that is, tissue immunohistochemical staining (IHC) (3+) or IHC (2+), and tissue fluorescence in situ hybridization (FISH) is positive.

结局指标

主要结局

Progression-Free Survival (PFS)

时间窗: 4 years

Defined as the time from initiation date of first cycle to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first.

次要结局

  • Disease Control Rate (DCR)(4 years)
  • Overall Survival (OS)(4 years)
  • Objective Response Rate (ORR)(4 years)
  • Duration Of Response (DOR)(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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