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

January 10, 2024 updated by: Xinxin Wang, Chinese PLA General Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Advanced gastric cancer patients receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-treatment
Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy
Drug: SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Procedure: Gastroscopic biopsy
Gastroscopy and biopsy
Post-treatment
Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy
Drug: SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Procedure: Gastroscopic biopsy
Gastroscopy and biopsy
Response
Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy
Drug: SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Procedure: Gastroscopic biopsy
Gastroscopy and biopsy
Non-response
Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy
Drug: SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Procedure: Gastroscopic biopsy
Gastroscopy and biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single-cell profiling
Time Frame: 6 months
Single-cell transcriptome and immune repertoire sequencing
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • scgc1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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