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NCT06202781 Clinical Trial

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

Gastric Cancer Clinical Trial

Official title:
Using Single-cell Sequencing to Explore Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06202781
Other study ID # scgc1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date July 31, 2024

Study information
Verified date January 2024
Source Chinese PLA General Hospital
Contact Xinxin Wang, MD
Phone 0086-10-938328
Email wangxx301@outlook.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 28
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Procedure:
• Gastroscopic biopsy
Gastroscopy and biopsy

Locations
Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Single-cell profiling Single-cell transcriptome and immune repertoire sequencing 6 months
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