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

Recruiting

• Conditions: Chemotherapy; Gastric Cancer; Tumor Microenvironment; Immunotherapy
• Interventions: Drug: SOX plus PD-1 inhibitor; Procedure: Gastroscopic biopsy

• Registration Number: NCT06202781
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-treatment	SOX plus PD-1 inhibitor	Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy
Pre-treatment	Gastroscopic biopsy	Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy
Non-response	SOX plus PD-1 inhibitor	Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy
Post-treatment	SOX plus PD-1 inhibitor	Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy
Post-treatment	Gastroscopic biopsy	Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy
Response	SOX plus PD-1 inhibitor	Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy
Response	Gastroscopic biopsy	Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy
Non-response	Gastroscopic biopsy	Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy

Primary Outcome Measures

Name	Time	Method
Single-cell profiling	6 months	Single-cell transcriptome and immune repertoire sequencing

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China