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

NCT04850729 | Recruiting

• 1 other identifier: NFEC-2021-082
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Keywords

Gastric Cancer; Tumor Microenvironment

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR) rate

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

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

Secondary Outcomes (3)

• Pathological complete response (pCR) rate

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

• R0 resection rate

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

• Disease-free Survival (DFS)

  3 years

Interventions

non-intervention OTHER

non-intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically or cytologically confirmed locally advanced resectable gastric and gastro-oesophageal junction adenocarcinoma.

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.
• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Wangjun Liao, MD, PhD

CONTACT

86-20-62787731; nfyyliaowj@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 20, 2021
• Study Start: May 25, 2021
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)