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NCT Number: NCT04850729

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Wangjun Liao, MD, PhD

CONTACT

[email protected]

Wangjun Liao, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Non-intervention

Other

non-intervention

Primary outcomes

  1. Major pathologic response (MPR) rate

    Time frame: From the initiation date of first cycle to the date of surgery, an average of 10 weeks

    Defined as <10% residual viable tumor cells in the resection specimen after neoadjuvant drug treatment.

Secondary outcomes

  1. Pathological complete response (pCR) rate

    Time frame: From the initiation date of first cycle to the date of surgery, an average of 10 weeks

    Defined as the percentage of participants having a pathological complete response.

  2. R0 resection rate

    Time frame: From the initiation date of first cycle to the date of surgery, an average of 10 weeks

    Rate of microscopically margin-negative resection.

  3. Disease-free Survival (DFS)

    Time frame: 3 years

    Defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by the investigator.

Study contacts

Contact information is provided by the study sponsor or research team.

Wangjun Liao, MD, PhD

CONTACT

[email protected]

86-20-62787731

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2021
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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