Evaluating the impact of tumor microenvironment on treatment outcomes in advanced gastric cancer
An Observational Study of Relationship Between Perioperative Treatment Efficacy and The Tumor Microenvironment for Locally Advanced Resectable Gastric and Gastro-oesophageal Junction Adenocarcinoma
This study is trying to see how the environment around tumors in patients with advanced stomach cancer affects how well their treatment works.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 169 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04850729 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between the efficacy of perioperative drug treatment and the tumor microenvironment in patients with locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. By analyzing tumor microenvironment scores derived from transcriptomic data, the study seeks to identify potential biomarkers that can predict treatment outcomes and guide personalized immunotherapy strategies. Eligible patients will provide residual tumor tissue samples for analysis, and their treatment will follow established clinical guidelines. The goal is to enhance the understanding of how the tumor microenvironment influences treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with locally advanced resectable gastric or gastroesophageal junction adenocarcinoma who are willing to provide tumor tissue samples.
Not a fit: Patients with HER2-positive tumors or significant cardiovascular and cerebrovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for perioperative treatments, enhancing outcomes for those with gastric cancer.
How similar studies have performed: While the role of the tumor microenvironment in cancer treatment is being explored, this specific approach to linking TME scores with perioperative treatment outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Wangjun Liao, MD, PhD
- Email: nfyyliaowj@163.com
- Phone: 86-20-62787731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.