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Clinical Trials/NCT06202781
NCT06202781
Recruiting
Not Applicable

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

Chinese PLA General Hospital1 site in 1 country28 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Gastroscopic biopsy
Conditions
Gastric Cancer
Sponsor
Chinese PLA General Hospital
Enrollment
28
Locations
1
Primary Endpoint
Single-cell profiling
Status
Recruiting
Last Updated
2 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xinxin Wang

Prof.

Chinese PLA General Hospital

Eligibility Criteria

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.

Arms & Interventions

Response

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

Intervention: Gastroscopic biopsy

Pre-treatment

Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy

Intervention: SOX plus PD-1 inhibitor

Pre-treatment

Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy

Intervention: Gastroscopic biopsy

Post-treatment

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

Intervention: SOX plus PD-1 inhibitor

Post-treatment

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

Intervention: Gastroscopic biopsy

Response

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

Intervention: SOX plus PD-1 inhibitor

Non-response

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

Intervention: SOX plus PD-1 inhibitor

Non-response

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

Intervention: Gastroscopic biopsy

Outcomes

Primary Outcomes

Single-cell profiling

Time Frame: 6 months

Single-cell transcriptome and immune repertoire sequencing

Study Sites (1)

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