Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Chemotherapy; Gastric Cancer; Immunotherapy; Tumor Microenvironment

Treatments: Drug: SOX plus PD-1 inhibitor; Procedure: Gastroscopic biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT06202781

scgc1

Details and patient eligibility

About

The goal of this study is to analyze the tumor microenvironment (TME) in gastric cancer patients treated with combined immunotherapy and chemotherapy. The main questions it aims to answer are:

• Provide profiles of TME between pre-treatment and post-treatment to gain insights into the mechanisms of immunotherapy combined with chemotherapy in advanced gastric cancer
• Investigate the crucial factors affecting treatment efficacy by comparing gastric cancer patients with varying treatment responses

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-bedridden, aged 18 to 70 years old;
• Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
• Histologically confirmed gastric adenocarcinoma with evaluable lesions based on RECIST 1.1;
• Advanced gastric cancer;
• Ready for receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab

Exclusion criteria

• History of other malignant diseases in the last 5 years;
• Prior chemotherapy, radiotherapy or immunotherapy;
• Not receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab.

Trial design

28 participants in 4 patient groups

Pre-treatment

Description:

Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy

Treatment:

Drug: SOX plus PD-1 inhibitor

Procedure: Gastroscopic biopsy

Post-treatment

Description:

Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy

Treatment:

Drug: SOX plus PD-1 inhibitor

Procedure: Gastroscopic biopsy

Response

Description:

Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy

Treatment:

Drug: SOX plus PD-1 inhibitor

Procedure: Gastroscopic biopsy

Non-response

Description:

Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy

Treatment:

Drug: SOX plus PD-1 inhibitor

Procedure: Gastroscopic biopsy