Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy
NCT ID: NCT06202781
Last Updated: 2024-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
28 participants
OBSERVATIONAL
2022-07-01
2024-07-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Pre-treatment
Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy
SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Gastroscopic biopsy
Gastroscopy and biopsy
Post-treatment
Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy
SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
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
SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
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
SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Gastroscopic biopsy
Gastroscopy and biopsy
Interventions
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SOX plus PD-1 inhibitor
S-1, Oxaliplatin and nivolumab/sintilimab
Gastroscopic biopsy
Gastroscopy and biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior chemotherapy, radiotherapy or immunotherapy;
* Not receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab.
18 Years
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Xinxin Wang
Prof.
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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scgc1
Identifier Type: -
Identifier Source: org_study_id
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