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

Recruiting now

Conditions studied: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04850729

Run by

Nanfang Hospital, Southern Medical University

People needed

169

Starts

2021-05-25

Expected to finish

2026-04-01

Last updated by the study team

2025-05-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma at the stage of cT2-T4aNxM0 (AJCC 8th) without distant metastases and without infiltration of adjacent structures and organs.
• 18-75 years old.
• Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis.
• Patients agree to participate in the study and sign the informed consent.
• Patients need to receive perioperative drug therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

You may not qualify if…

• 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.
• Patients with major cardiovascular and cerebrovascular diseases (such as congestive heart failure, unstable heart colic, atrial fibrillation, stroke, transient ischemic attack, etc.).
• Allergies or contraindications to common chemotherapy drugs, immunotherapy drugs or the ingredients.
• Women who are pregnant, breast-feeding.
• Other conditions the investigator believes that it is not suitable to participate in this study.

Where it is running

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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