gastric cancer with No.16a2/b1 lymph node metastasis
Conditions
Interventions
Experimental group:Preoperative sintilimab plus nab-POS regimen
Experimental group:D2 surgery plus PAND
Experimental group:Postoperative treatment with oral S-1, intravenous sintilimab and intraperitoneal paclitaxel
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Aged between 18 and 75 years at registration; 2 Eastern Cooperative Oncology Group (ECOG) score = 3 months; 15. Written informed consent from patient.
Exclusion criteria
Exclusion criteria: 1. Synchronous or metachronous (within 5 years) malignancies; 2. HER2 positive; 3. Clinically significant bleeding symptoms or evident bleeding tendency within 3 months; 4. History of gastrointestinal perforation; 5. Active infection requiring antimicrobial treatment, active hepatitis, congenital or acquired immunodeficiency; 6. History or planned organ transplantation or allogeneic bone marrow transplantation; 7. Body temperature >= 38.0?; 8. Emergency surgery; 9. During pregnancy, within 28 days of post parturition, or during lactation; 10. Any active autoimmune disease or history of autoimmune disease with relapse risk; 11. Taking immunosuppressive drugs or systemic corticosteroid treatment within 7 days; 12. Severe mental disease, uncontrolled epilepsy, or central nervous system disease; 13. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months; 14. Clinical manifestations or diseases of the heart: New York Heart Association grade >= 2 heart failure or color Doppler echocardiography showing left ventricular ejection fraction 450 ms in males or >470 ms in females; resting ECG showing abnormalities of important clinical significances, complete left bundle branch block, grade 2-3 heart block, or PR interval >250 ms; and having factors that can increase the risks of QTc prolongation or heart rate abnormalities; 15. Current interstitial pneumonia or interstitial lung disease; history of interstitial pneumonia or interstitial lung disease requiring steroid treatment; pulmonary fibrosis, cryptogenic organizing pneumonia, pneumoconiosis, drug-related pneumonia, or idiopathic pneumonia that can influence the assessment and treatment of immune-related pulmonary toxicity; CT showing active pneumonia or severe pulmonary dysfunction at screening; or active pulmonary tuberculosis. 16. Uncontrolled diabetes mellitus or hypertension; 17. Receiving attenuated live vaccine within 28 days or intending to receive attenuated live vaccine during the treatment period; 18. Allergic to any study drug or ingredient; 19. Participating in other clinical trials; 20. Any other factors that can influence the study results or lead to study termination, as deemed by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival;3-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival;objective response rate;incidence of postoperative complications;adverse events; | — |
Countries
China
Contacts
Public ContactChao Yan
Outcome results
None listed