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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Chemotherapy
• Gastric Cancer
• Immunotherapy
• Stomach Neoplasms

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