Gastric Cancer
Conditions
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed gastric adenocarcinoma (G); 2. According to AJCC 8th edition gastric cancer staging, the clinical staging of enrolled patients was cT3-4aN+M0 or cT4bNanyM 0 by endoscopic ultrasound (EUS) or enhanced CT/MRI scanning. Or cT3-4aN+M1 with CY1 alone, or cT4bNanyM 1; 3. According to RESIST 1.1, abdominal CT/MRI requires at least one evaluable lesion; 4. The physical status score of the Eastern Co-operative Oncology Group (ECOG) is 0-1; 5. The physical state or organ function could tolerate the treatment of the study regimen, including SOX regimen chemotherapy, PD-1 monoclonal antibody therapy and major abdominal surgery. 6. Baseline blood routine and biochemical indicators of subjects meet the following standards: (1).Blood routine: neutrophil absolute count (ANC)>=1.5×10^9/L; Platelet p 100 x 10^9 / L; Hemoglobin >=90g/L. (2).Liver function: total bilirubin = 30g/L. (3). Renal function: serum creatinine =60ml/min. (4). Coagulation function: INR/PT=6 months. 8. Male or female. Age >=18 years and <=75 years; 9. Sign a written informed consent prior to enrollment; 10. Willingness to follow research protocols and procedures, including laboratory tests, complementary tests and treatment; 11. Female patients should not be pregnant or breast-feeding; 12. Female patients agreed to use contraception during treatment and within 120 days after the last dose of PD-1 monoclonal antibody, or within 180 days after the last dose of chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Peritoneal implantation (P1), distant viscera or distant lymph node metastasis (M1); 2. According to endoscopic ultrasound (EUS) or enhanced CT/MRI scanning, the stage of the primary lesion was cT1/2; 3. Patients who have previously received radiotherapy, chemotherapy, radical excision or immunotherapy for gastric cancer, except steroid drugs; 4. Previous liver and kidney radiation therapy; 5. Women who are pregnant or nursing. Women of childbearing age who tested positive or did not have a pregnancy test at baseline; Menopausal women must stop menstruating for at least 12 months before pregnancy is considered impossible; 6. Men and women who had sex (with the possibility of procreation) were reluctant to use contraception during the study period; 7. Patients with a history of other malignant diseases in the last 5 years, excluding the diseases covered in this study, cured basal cell carcinoma of the skin, carcinoma in situ of the skin, Superficial bladder cancer, carcinoma in situ of the cervix and carcinoma in situ of the breast; 8. Known central nervous system tumors, including brain metastases; 9. Uncontrollable pleural effusion, pericardial effusion or abdominal effusion occurred within 2 weeks prior to enrollment; 10. Patients with gastrointestinal bleeding or high risk of bleeding within the first 2 weeks of enrollment; 12. Patients with upper digestive tract obstruction, functional abnormalities or malabsorption syndrome may affect the absorption of oral chemotherapy drugs; 13. The patient cannot swallow or take medication orally; 14. Pulmonary embolism occurred within 28 days prior to enrollment; 15. Pulmonary history: interstitial pulmonary disease, non-infectious pneumonia, pulmonary fibrosis, acute pulmonary disease; 16. Other possibilities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical down-staging rate;3-years disease-free survival rate;safety profile;5-years survival rate;Major pathological response rate; | — |
Countries
China
Contacts
Public ContactZhou Jin
The First Affiliated Hospital of Soochow University
Outcome results
None listed