Gastric CancerNCT06202781
Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy
An observational study of Gastric Cancer and Tumor Microenvironment, run by Chinese PLA General Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Tumor Microenvironment, Immunotherapy
- What is being tested?
- SOX plus PD-1 inhibitor and Gastroscopic biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 9 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced gastric cancer patients receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Gastric Cancer, Tumor Microenvironment, Immunotherapy, Chemotherapy
- Being tested
- SOX plus PD-1 inhibitor, Gastroscopic biopsy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOX plus PD-1 inhibitorDrug
S-1, Oxaliplatin and nivolumab/sintilimab
Gastroscopic biopsyProcedure or surgery
Gastroscopy and biopsy
| Study group | Role | What they receive |
|---|---|---|
| Pre-treatment | Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy Receives: Drug: SOX plus PD-1 inhibitor; Procedure: Gastroscopic biopsy | |
| Post-treatment | Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy Receives: Drug: SOX plus PD-1 inhibitor; Procedure: Gastroscopic biopsy | |
| Response | Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy Receives: Drug: SOX plus PD-1 inhibitor; Procedure: Gastroscopic biopsy | |
| Non-response | Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy Receives: Drug: SOX plus PD-1 inhibitor; Procedure: Gastroscopic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-cell profiling
Single-cell transcriptome and immune repertoire sequencing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jul 2022
- Primary completion30 Sep 2026
- Study completion9 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinxin Wang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202781
- Sponsor's protocol ID
- scgc1
- Status last verified
- Aug 2026
- First submitted
- 1 Jan 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Single-cell Sequencing to Explore Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy
- ClinicalTrials.gov ID
- NCT06202781
- Acronym / sponsor ID
- scgc1
- Conditions
- Gastric Cancer, Tumor Microenvironment, Immunotherapy, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 9 Oct 2026 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-treatment | – | Drug: SOX plus PD-1 inhibitor, Procedure: Gastroscopic biopsyAdvanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy |
| Post-treatment | – | Drug: SOX plus PD-1 inhibitor, Procedure: Gastroscopic biopsyAdvanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy |
| Response | – | Drug: SOX plus PD-1 inhibitor, Procedure: Gastroscopic biopsyAdvanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy |
| Non-response | – | Drug: SOX plus PD-1 inhibitor, Procedure: Gastroscopic biopsyAdvanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced gastric cancer patients receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOX plus PD-1 inhibitorS-1, Oxaliplatin and nivolumab/sintilimab | Drug | Non-response, Post-treatment, Pre-treatment, Response |
| Gastroscopic biopsyGastroscopy and biopsy | Procedure or surgery | Non-response, Post-treatment, Pre-treatment, Response |
Primary outcome
Single-cell profiling
Time frame: 6 months
Single-cell transcriptome and immune repertoire sequencing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Tumor Microenvironment, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-cell profiling (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.