Gastric Cancer
Conditions
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, aged 18-75 years; 2. ECOG score 0-1; 3. Newly treated patients diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histology; 4. The molecular typing test is HER2 negative; 5. Perform clinical staging based on enhanced CT/MRI examination (combined with ultrasound gastroscopy and diagnostic laparoscopic exploration when necessary), and the stages are C-stage II, III(T1-4a N+ M0, T3–4a N0 M0, AJCC eighth CTNM staging of gastric cancer); 6. The research center and the surgeon can complete radical D2 lymph node dissection (the number of lymph nodes checked must be at least 15 to ensure the quality of the operation) surgery, and the resection reaches R0; 7. Physical condition and organ function allow for larger abdominal surgery; 8. It has sufficient organ and bone marrow function, defined as follows: (1) Blood routine: absolute neutrophil count (ANC)>= 1.5 x 109/L; platelet count (PLT)>= 100 x 10^9/L; hemoglobin content (HGB) >= 9.0 g/dL; (2) Liver function: patients without liver metastasis require serum total bilirubin (TBIL) =50 mL/min (calculated by Cockcroft/Gault formula): Female: Ccr= (140-years old) x weight (kg) x 0.85/(72 x serum creatinine (mg/dL)) Male: Ccr= (140-years old) x weight (kg) x 1.00/(72 x serum creatinine (mg/dL)); (4) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) =50%; 10. Agree and be able to comply with the plan during the research period; 11. Provide written informed consent before entering the study screening, and the patient has understood that they can withdraw from the study at any time during the study without any loss; 12. Agree to provide blood and histological specimens.
Exclusion criteria
Exclusion criteria: 1. Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome; 2. Severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe kidney injury; 3. Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.; 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. Uncontrollable pleural effusion, pericardial effusion or ascites; 6. Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure >= Grade II, uncontrolled arrhythmia, and myocardial infarction; 7. Have an allergic reaction to the drugs used in this study; 8. Use steroids or other systemic immunosuppressive therapies 14 days before enrollment; 9. Patients who received study drug treatment within 4 weeks before enrollment (participated in other clinical trials); 10. Active autoimmune diseases; 11. History of primary immunodeficiency; 12. Have used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10mg/day splash nisone or other glucocorticoids in equivalent doses), or use hormones to prevent allergy to contrast agents; 13. Receive live attenuated vaccines within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccines during the study period; 14. Known to have active tuberculosis; 15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 16. HIV antibody positive, active hepatitis B or C (HBV, HCV); 17. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical down-staging rate;3-years disease-free survival rate;major pathological response;5-years survival rate;safety profile;objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactLiang Han
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed