Gastric Cancer
Conditions
Interventions
SOX group VS SOX+ albumin paclitaxel group VS SOX+PD1 group:Voluntary grouping of patients
Sponsors
Shanghai General Hosiptal
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. D2 radical resection was performed within 6 weeks before enrollment, reaching R0 resection with negative margins; 2. Aged 20-75 years old; 3. Gastric cancer was diagnosed for the first time by gastroscopic biopsy in our hospital; 4. Resectable stage III gastric tumor with clinical stage cTNM confirmed by computed tomography (CT) and/or magnetic resonance imaging (MRI) according to the 8th edition of the American Joint Committee on Cancer (AJCC) criteria. 5. The clinical diagnosis is primary gastric cancer, and the postoperative histopathology is stage III according to the eighth edition of AJCC pTNM staging; 6. Patients with an ECOG score of 0-2 who can tolerate chemotherapy; 7. Expected lifespan > 12 months; 8. Except for primary tumor surgery, the patient has not received anti-tumor therapy (including systemic chemotherapy and local radiotherapy) before; 9. Patients can understand this study; patients and/or legal representatives voluntarily agree to participate in this study and sign the informed consent form, and can abide by the visits and related procedures specified in the protocol; 10. Have sufficient organ and bone marrow function, and the laboratory test values ??within 7 days before enrollment meet the following requirements, as follows: blood routine: neutrophils >=1.5x10^9/L, platelets >=75x10^9/ L, hemoglobin >= 80g/L, white blood cells (WBC) >= 3.0x10^9/L, liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) all less than or equal to 2.5 x upper limit of normal; liver function: albumin >= 28g/L; renal function: serum creatinine 60 ml/min.
Exclusion criteria
Exclusion criteria: 1. Previous surgical contraindications including abnormal coagulation function and cardiopulmonary diseases; 2. Human epidermal growth factor receptor-2 positive (HER-2 positive); 3. History of previous gastrointestinal perforation and/or fistula, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive small bowel resection complicated with chronic diarrhea, Crohn's disease, ulcerative colitis or long-term chronic diarrhea ; 4. Those who have experienced esophageal or gastric varices bleeding events caused by portal hypertension in the past, and who have a high risk of bleeding as assessed by the investigator; 5. Any life-threatening bleeding events in the past 3 months, including the need for blood transfusion, surgery or local treatment, and continuous drug treatment; 6. History of other primary malignant tumors in the past; 7. Preoperative abdominal contrast-enhanced CT and other imaging or histological/cytological pathology showed distant metastasis. Patients with peritoneal metastasis, liver and other important organ diseases found during operation; 8. Human immunodeficiency virus (HIV) infection (HIV antibody positive), active HCV and HBV infection; 9. Uncontrolled serious medical conditions that the investigator believes will affect the subject's treatment plan, the patient has postoperative complications that require clinical intervention and affect treatment, such as gastroparesis, dumping syndrome, a combination of serious medical conditions, Including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, etc.; 10. Contraindications to adjuvant chemotherapy. Known or suspected allergy to the drug or any drug associated with this study; 11. Female patients who are pregnant or breastfeeding; 12. Uncontrolled hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 13. Congenital or acquired immunodeficiency; 14. History or planning history of organ transplantation or bone marrow transplantation; 15. History of any active autoimmune disease or autoimmune disease at risk of recurrence, including autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism. need to take glucocorticoids, etc.; 16. Participants with skin diseases that require systemic treatment (such as leukoderma, psoriasis, and alopecia) or type 1 diabetes that cannot be controlled by insulin therapy, or who have a history of asthma that requires intervention, and asthma participants who require bronchodilators; 17. Within 7 days before randomization (>10 mg/day prednisone or other equivalent drugs), taking immunosuppressive drugs or receiving systemic corticosteroids; 18. Participate in other clinical trials; 19. Any other factors that the investigator believes may affect the results of the study or lead to the termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| over all survival; | — |
Countries
China
Contacts
Public ContactHuang Chen
Shanghai General Hosiptal
Outcome results
None listed