Gastric cancer
Conditions
Interventions
Experimental group:carrelizumab
Sponsors
Affilicated Huai'an First people's hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form before joining the group; 2. Aged 18 to 75 years, both male and female; 3. ECOG score: 0-1; 4. Her2 negative gastric adenocarcinoma/gastroesophageal junction adenocarcinoma confirmed by histology, no anti-tumor chemotherapy/immunotherapy has been performed in the past; 5. According to AJCC 8th edition pTNM staging is pT1-4a/bN+M0, ?B/?C stage; 6. The D2 radical resection performed by the subject must meet the technical standards recognized by the center (refer to the D2 radical resection standard of the "Guidelines for Gastric Cancer in Japan 2018 Edition"); 7. The expected survival period is more than 6 months; 8. The baseline blood routine and biochemical indicators of the selected patients should meet the following standards: hemoglobin >=90g/L, absolute neutrophil count >=1.5x10^6/L, platelet count >=100x10^9/L, aspartic acid Or alanine aminotransferase =30g/L, INR/PT<=1.5x ULN, aPTT<= 1.5x ULN; 9. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo surgical sterilization must be negative in serum or urine HCG within 7 days before enrollment in the study; and must be non-lactating; male patients of childbearing age who are not surgically sterilized or sterilized must agree with their spouse during the study treatment period and the study Use a medically approved contraceptive method within 3 months after the end of the treatment period. 10. The subject voluntarily joined the study, with good compliance, no other treatment contraindications, and agreed to provide blood samples and histological specimens to cooperate with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or women of childbearing age have a positive baseline pregnancy test; 2. Diagnose distant metastasis by CT/MR/EUS; 3. Received previous anti-tumor treatment, including chemotherapy, radiotherapy or immunotherapy; 4. Suffered from other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer); 5. Suffered from severe cardiovascular disease in the 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure >= Grade II, uncontrolled arrhythmia, and myocardial infarction; 6. Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome, which may affect the absorption of capecitabine; 7. Severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe kidney injury; 8. Have an allergic reaction to the drugs used in this study; 9. Use steroids or other systemic immunosuppressive therapies 14 days before enrollment; 10. Patients who received study drug treatment within 4 weeks before enrollment (participated in other clinical trials). 11. Active autoimmune diseases 12. History of primary immunodeficiency 13. Have used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10mg/day Nisone or other glucocorticoids in equivalent doses), or use hormones to prevent allergy to contrast agents. 14. Within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccine 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 believes that it should be excluded from this study. For example, the investigator judges that the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment. Serious laboratory examination abnormalities, accompanied by family or social factors, will affect the safety of subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;safety; | — |
Countries
China
Contacts
Public ContactGao Yong
Affilicated Huai'an First people's hospital of Nanjing Medical University
Outcome results
None listed