Gastric cancer
Conditions
Interventions
singel arm :neoadjuvant chemotherapy with Sintilimab
Sponsors
Tianjin Medical University Cancer Institute and Hospital Department of Gastric Oncology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 years; 2. ECOG score 0-2; 3. Untreated patients histologically diagnosed with locally advanced gastric adenocarcinoma 4. Based on enhanced CT/MRI combined with ultrasonic gastroscopy and diagnostic (necessary laparoscopic surgical exploration) for clinical stage: c stage II and III (T1-4 a/N + M0, T3, 4 a/N - M0, AJCC eighth edition cTNM staging gastric cancer); 5. The center and the surgeon can complete radical D2 lymph node dissection (the number of lymph nodes examined must be at least 15 to ensure the quality of the operation) surgery and R0 resection; 6. Physical condition and visceral function allow for major abdominal surgery; 7. Having adequate organ and bone marrow functions, as defined below: 1) Blood routine examination: Absolute neutrophil count (ANC) >=1.5x10^9/L;Platelet count (PLT) >=100x10^9/L; Hemoglobin content (HGB) >=9.0 g/dL; 2) Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) =50 mL/min (calculated with Cockcroft/Gault formula) : -Female: Ccr= (140- age) x weight (kg) x 0.85; 72 x serum creatinine (mg/dL); -Male: Ccr= (140- age) x weight (kg) x 1.00; 72 x serum creatinine (mg/dL) 4) Full coagulation function, defined as international standard ratio (INR) or prothrombin time (PT) =50%; 9. Agree and comply with the protocol for the study period; 10. Written informed consent is provided prior to entering the study screening, and the patient is understood to be able to withdraw from the study at any time with no loss; 11. Agree to provide blood and histological specimens.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Received prior antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy; 3. Having other malignant neoplasms (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ) in the past 5 years; 4. Uncontrollable pleural effusion, pericardial effusion, or ascites; 5. Severe cardiovascular disease, such as symptomatic coronary heart disease, congestive heart failure >=GRADE II, uncontrolled arrhythmia, myocardial infarction within 12 months prior to enrollment; 6. Complicated with upper gastrointestinal obstruction/bleeding or digestive dysfunction or malabsorption syndrome; 7. A complication of severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe renal injury; 8. Allergic reactions to drugs used in this study; 9. Use of steroids or other systemic immunosuppressive therapy within 14 days prior to enrollment; 10. Patients who received the study drug within 4 weeks of enrollment (participating in other clinical trials); 11. Active autoimmune disease; 12. A history of primary immunodeficiency; 13. immunosuppressive drugs were administered within 4 weeks prior to the first study treatment, excluding nasal spray, inhalational or other topical corticosteroids or systemic glucocorticoids at physiological doses (i.e., not exceeding 10mg/ day of prednisone or equivalent doses of other corticosteroids), or to prevent contrast agent allergy; 14. Receive live attenuated vaccine within 4 weeks prior to the first study treatment or plan to receive live attenuated vaccine during the study; 15. Known to have active tuberculosis; 16. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation are known; 17. HIV antibody positive, active hepatitis B or C (HBV, HCV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-years disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-years overall survival rate;Disease control rate;Safety profile; | — |
Countries
China
Contacts
Public ContactDing Xuewei
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed