NCT04850729

Relationship Between Perioperative Treatment Efficacy and The Tumor Microenvironment for Locally Advanced Resectable Gastric Cancer.

An Observational Study of Relationship Between Perioperative Treatment Efficacy and The Tumor Microenvironment for Locally Advanced Resectable Gastric and Gastro-oesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 169 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Perioperative drug treatment has gradually become the standard regimen for locally advanced gastric cancer, whereas only a subset of patients could benefit from it. Therefore, one major challenge for perioperative drug treatment is to construct promising biomarkers and to screen out potential beneficial patients. Recent evidence has revealed that tumor microenvironment (TME) is highly associated with the prognosis of gastric cancer. Meanwhile, tumor microenvironment score (TMEscore) established with transcriptomic data is a robust biomarker for predicting prognosis and guiding individualized immunotherapy strategies. However, its predictive value for perioperative drug treatment outcomes warrants further exploration and validation. The study is a multi-center, observational study to evaluate the relationship between the efficacy of perioperative treatment and tumor microenvironment in patients with locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma, aiming at further determining the predictive value of TMEscore and establishing a comprehensive treatment-efficacy evaluation system for gastric cancer.

Detailed description

Perioperative drug treatment has gradually become the standard regimen for locally advanced gastric cancer, whereas only a subset of patients could benefit from it. Therefore, one major challenge for perioperative drug treatment is to construct promising biomarkers and to screen out potential beneficial patients. Recent evidence has revealed that tumor microenvironment (TME) is highly associated with the prognosis of gastric cancer. Meanwhile, tumor microenvironment score (TMEscore) established with transcriptomic data is a robust biomarker for predicting prognosis and guiding individualized immunotherapy strategies. However, its predictive value for perioperative drug treatment outcomes warrants further exploration and validation. The study is a multi-center, observational study to evaluate the relationship between the efficacy of perioperative treatment and tumor microenvironment in patients with locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma, aiming at further determining the predictive value of TMEscore and establishing a comprehensive treatment-efficacy evaluation system for gastric cancer. Eligible subjects were selected according to the inclusion criteria and exclusion criteria. After the successful screening, the patients were treated in accordance with the clinical guidelines and the actual conditions. The residual tissue samples of the primary tumor were collected to conduct the tumor microenvironment detection. After routine neoadjuvant therapy, followed by a restaging of the tumor status and surgery. The residual surgical specimens were collected to conduct the tumor microenvironment detection analysis.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
OTHER	non-intervention	non-intervention

Timeline

• Start date: 2021-05-25
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-04-20
• Last updated: 2025-05-30

Locations

1 site across 1 country: China