Adenocarcinoma of the stomach/gastroesophageal junction
Conditions
Interventions
Control group:Chemotherapy of oxaliplatin plus S-1
Experimental group:Oxaliplatin combined with S-1 (SOX) regimen followed by radiotherapy plus PD-1 antibody
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients have good compliance, can understand the research process of this study, and sign written informed consent 2. Age 18~75 years old; 3. Patients with adenocarcinoma of the stomach or gastroesophageal junction confirmed by pathological histology; 4. According to the AJCC/UICC version 8 staging, the postoperative lymph node stage is N3; 5. D2 radical resection and R0 resection criterion; 6. Within 4~6 weeks after surgery, oxaliplatin combined with Tigio regimen can be started; 7.PS (physical condition) score 0-1; 8. Bone marrow function: neutrophil >=1.5×10^9/L, platelet >=100×10^9/L, hemoglobin >=90g/L; 9. Liver and kidney function: serum creatinine < = 1 times the upper limit of normal value; AST and ALT < = 2 times the upper limit of normal, total bilirubin < = 1.5 times the upper limit of normal; 10. Non-pregnant and lactating females, females/males of childbearing potential should use effective contraception during the study and for 6 months after the end of study treatment; 11. There are no contraindications to the use of oxaliplatin and tigio; 12. Agree to provide histological samples.
Exclusion criteria
Exclusion criteria: 1. Patients with gastric cancer with distant metastases; 2. Patients who have received neoadjuvant therapy or other drug-assisted therapy in the past; 3. Those with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, and the investigator shall judge whether its clinical severity prevents the signing of the informed consent form or affects the patient's compliance with oral medications; 4. Clinically serious (i.e., active) cardiac disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) Class II or greater congestive heart failure or severe arrhythmia requiring medical intervention, or history of myocardial infarction within the last 12 months. Those who require immunosuppressive therapy for organ transplantation; 5. Severe uncontrolled recurrent infection, or other serious uncontrolled concomitant diseases. Severe chronic or active infection, including tuberculosis infection, requiring systemic antibacterial, antifungal or antiviral therapy; 6. Severe respiratory diseases; 7. Severe hepatic and renal insufficiency; 8. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs; 9. Patients with active autoimmune disease or a history of autoimmune disease that may recur: Patients with the following diseases are not excluded and can be entered for further screening: Controlled type 1 diabetes b. Hyperthyroidism or hypothyroidism (if controlled with hormone replacement therapy alone) c. Controlled celiac disease d. Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of external triggers 10. History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.; 11. Known history of HIV infection; 12. Untreated chronic hepatitis B or chronic HBV carriers, if the hepatitis B virus (HBV) DNA exceeds the ULN, or the hepatitis C virus (HCV) RNA positive patients should be excluded; 13. Those who have continued glucocorticoid therapy (except topical application) within 1 month or need immunosuppressive therapy for organ transplantation; 14. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency; 15. Presence of Grade II or above peripheral neuropathy according to NCI CTC-AE v5.0 criteria; 16. Patients who are known to be allergic to or intolerant to chemotherapy drugs or their excipients; 17. Postoperative complications that require clinical intervention and affect treatment, such as gastric paralysis, dumping syndrome, etc.; 18. Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma; 19. Pregnant or lactating women; 20. Participated in other pilot studies within 30 days before the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of disease free survival at 3-year;The rate of disease free survival at 5-year;The rate of overall survival at 3-year;The rate of overall survival at 5-year;Overall survival;Safety assessment; | — |
Countries
China
Contacts
Public ContactCui Yuehong
Zhongshan Hospital Fudan University
Outcome results
None listed