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

Gastric Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850729
• Other study ID #: NFEC-2021-082
• Status: Recruiting
• Start date: May 25, 2021
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Wangjun Liao, MD, PhD
• Phone: 86-20-62787731
• Email: nfyyliaowj[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 169
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Intervention

Other:
• non-intervention
non-intervention

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pathological complete response (pCR) rate	Defined as the percentage of participants having a pathological complete response.	From the initiation date of first cycle to the date of surgery, an average of 10 weeks
Secondary	R0 resection rate	Rate of microscopically margin-negative resection.	From the initiation date of first cycle to the date of surgery, an average of 10 weeks
Secondary	Disease-free Survival (DFS)	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.	3 years