NCT04850729 Relationship Between Perioperative Treatment Efficacy and The Tumor Microenvironment for Locally Advanced Resectable Gastric Cancer.
| NCT ID | NCT04850729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Gastric Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 169 participants |
| Start Date | 2021-05-25 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 169 participants in total. It began in 2021-05-25 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. 18-75 years old. 3. Willing to provide residual tumor tissues after routine clinical diagnosis for tumor microenvironment detection analysis. 4. Patients agree to participate in the study and sign the informed consent. 5. Patients need to receive perioperative drug therapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Exclusion Criteria: 1. 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. 2. Patients with major cardiovascular and cerebrovascular diseases (such as congestive heart failure, unstable heart colic, atrial fibrillation, stroke, transient ischemic attack, etc.). 3. Allergies or contraindications to common chemotherapy drugs, immunotherapy drugs or the ingredients. 4. Women who are pregnant, breast-feeding. 5. Other conditions the investigator believes that it is not suitable to participate in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04850729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04850729 currently recruiting?
Yes, NCT04850729 is actively recruiting participants. Contact the research team at nfyyliaowj@163.com for enrollment information.
Where is the NCT04850729 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04850729 clinical trial?
NCT04850729 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 169 participants.