gastric cancer
Conditions
Interventions
Experimental group:Standard neoadjuvant therapy. Neoadjuvant chemotherapy: 130 mg/m 2 intravenous drip, administered on the first day of each 3-week cycle
S-1 (tegafur immediate Oteracil): 60 mg orally, 60 mg each time, twice a day. The administration period is the first two weeks (days 1-14) of each three week treatment cycle, and then the drug is stop
Control group:Standard neoadjuvant therapy. Neoadjuvant chemotherapy: 130 mg/m 2 intravenous drip, administered on the first day of each 3-week cycle
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, male or female; 2. Histologically or cytologically confirmed diagnosis of gastric cancer; 3. Have not received neoadjuvant therapy with immune checkpoint inhibitors (ICIs) or other immunotherapies, and are planned to receive neoadjuvant therapy with the standard oxaliplatin plus S-1 (tegafur-gimeracil-oteracil) regimen; 4. Have a clear clinical stage and meet the criteria for receiving neoadjuvant therapy followed by surgical resection; 5. Expected survival >= 3 months; 6. Routine blood test, liver function, renal function, and cardiac function are within the safe range for drug administration; 7. Able to understand the study content and sign written informed consent; 8. Willing and able to complete visits, treatment, and follow-up as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Known allergy to green tea extract or EGCG. 2. Previous severe intolerance or severe allergic reaction to chemotherapeutic agents or immunotherapeutic agents. 3. Presence of active autoimmune disease. 4. Long-term use of immunosuppressants (e.g., glucocorticoids, cyclosporine, etc.). 5. Patients who have received or plan to receive neoadjuvant therapy with immunotherapy. 6. Pregnant or breastfeeding women. 7. Major organ dysfunction, such as severe cardiac dysfunction, severe hepatic insufficiency, severe renal insufficiency, or other conditions that make the patient unsuitable for neoadjuvant therapy. 8. Concurrent presence of another malignancy. 9. Severe infection or other acute illness that may affect study safety or compliance. 10. Inability to understand or comply with protocol requirements, making it difficult to complete visits or follow-up as expected. 11. Recent participation in another clinical trial that may interfere with the study intervention or outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treg ratio and Treg/CD8+T cell ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by imaging;Expression levels of CD8+T cell activation markers (gzmB, IFN - ?);Changes of NK cells, dendritic cells and other key immune cells;Progression free survival (PFS) and overall survival (OS); | — |
Countries
China
Contacts
Public ContactChen Huang
Shanghai General Hospital
Outcome results
None listed