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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое non-intervention
  non-intervention

Первичные конечные точки

• Major pathologic response (MPR) rate [Срок оценки: From the initiation date of first cycle to the date of surgery, an average of 10 weeks]

Вторичные конечные точки (3)

• Pathological complete response (pCR) rate [Срок оценки: From the initiation date of first cycle to the date of surgery, an average of 10 weeks]
• R0 resection rate [Срок оценки: From the initiation date of first cycle to the date of surgery, an average of 10 weeks]
• Disease-free Survival (DFS) [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Nanfang Hospital, Southern Medical University — Гуанчжоу

Публикации

• Shi M, Zeng D, Luo H, Xiao J, Li Y, Yuan X, Huang N, Wu J, Zheng S, Wu J, Li S, Rong X, Wang C, Jiang L, Mao Q, Qiu W, Guo J, Deng Q, Sun H, Lu X, Yu Y, Lai Y, Fang Y, Zhou R, Wang L, Huang X, Kong Y, Li J, Liang L, Bin J, Liao Y, Liao W. Tumor microenvironment RNA test to predict immunotherapy outcomes in advanced gastric cancer: The TIMES001 trial. Med. 2024 Nov 8;5(11):1378-1392.e3. doi: 10.101 PMID 39089261

Идентификаторы

NCT: NCT04850729 · NFEC-2021-082

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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