Gastric/ Gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental group:Adbelizumab +SOX
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before enrollment 2. Age 18-75 years old, male and female 3. ECOG score: 0 ~ 1 4. Patients with gastric adenocarcinoma confirmed by pathology, PD-L1 positive population (expression = 1%) 5. D2 radical surgery was performed without preoperative treatment 6. Patients without residual cancer (R0) who underwent gastrectomy had not previously received anti-tumor chemoradiotherapy/immunotherapy 7. Postoperative stage II-III according to AJCC 8th edition 8. Expected survival is greater than 6 months 9. Baseline blood routine and biochemical indices of enrolled patients should meet the following criteria: hemoglobin =90g/ L, absolute neutrophil count =1.5×10?/ L, platelet count =100×10?/ L, aspartate or alanine aminotransferase = 2.5 times the upper limit. Alkaline phosphatase = 2.5 times the upper limit of normal (ULN), total serum bilirubin < 1.5 times ULN, serum creatinine <1 times ULN, serum albumin =30g/ L, INR /PT=1.5x ULN, aPTT=1.5x ULN 10. Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Women of reproductive age who were not surgically sterilized had to be negative for serum or urine HCG within 7 days prior to study enrollment. And must be non-lactation period; Male patients of non-surgical sterilization or reproductive age need to consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period. 11. The subjects voluntarily joined the study with good compliance and no other treatment contraindications, and agreed to provide blood samples and histological specimens, as well as safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. A woman who is pregnant or breastfeeding, or a woman of childbearing age who has a positive baseline pregnancy test; 2. Remote metastases were diagnosed by CT /MR/ EUS. 3. Received prior anti-tumor therapy, including chemotherapy, radiation, or immunotherapy; 4. have had other malignancies in the past 5 years (other than basal cell or squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ); 5. Severe cardiovascular disease, such as symptomatic coronary heart disease, = grade II congestive heart failure, uncontrolled arrhythmia, or myocardial infarction, in the 12 months prior to enrollment; 6. Upper gastrointestinal obstruction/bleeding or digestive dysfunction or malabsorption syndrome may affect the absorption of S-1; 7. Severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe kidney injury; 8. Allergic reaction to the drugs used in this study; 9. Use steroids or other systemic immunosuppressive therapy for 14 days prior to enrollment; 10. Patients who received the investigational drug within the first 4 weeks of enrollment (participating in other clinical trials). 11. Active autoimmune disease 12. History of primary immunodeficiency 13. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study therapy, excluding nasal, inhaled, or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10mg/ day of prednisone or equivalent doses of other corticosteroids), or use of hormones to prevent hypersensitivity to contrast media. 14. Receive live attenuated vaccine within 4 weeks prior to the first dose of study treatment or during the study period. 15. Known to have active tuberculosis. 16. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 17. HIV antibody positive, active hepatitis B or C (HBV HCV). 18. The investigator considers that the subjects should be excluded from this study, for example, if the investigator judges that the subjects have other factors that may lead to the forced termination of the study, such as other serious illnesses (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1y-DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1y-OS;DFS;OS; | — |
Countries
China
Contacts
Public ContactTongshan Wang
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Outcome results
None listed