peri-operative sintilimab in combination with sox in locally advanced gastric cancer

Conditions: Gastric Cancer; Perioperative; Sintilimab

Summary: to evaluate efficacy and safety of peri-operative sintilimab in combination with sox in resectable locally advanced gastric or gastroesophageal junction adenocarcinoma


Eligibility criteria:
inclusion criteria: * male or female, 18 years old ≤ age ≤ 75 years old * ecog ps score 0-1 * treatment naive patients diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histopathology * no known her2-positive status; * clinical stage ⅱ, ⅲ (t1-4a n+ m0, t3-4a n0 m0, ajcc 8th) * the research center and the surgeon can complete d2 radical gastrectomy * physical condition and organ function allow for larger abdominal surgery * sufficient organ and bone marrow function, which is defined as follows: 1. blood routine: absolute neutrophil count (anc)≥1.5×109/l; platelet count (plt)≥100×109/l; hemoglobin content (hgb)≥9.0 g/dl. 2. liver function: patients without liver metastasis require serum total bilirubin (tbil) ≤1.5×upper limit of normal (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2.5 ×uln; 3. renal function: creatinine clearance rate (ccr) ≥50 ml/min (calculated by cockcroft/gault formula): 1. female: ccr= (140-years old) x weight (kg) x 0.85/(72 x serum creatinine (mg/dl)) 2. male: ccr= (140-years old) x weight (kg) x 1.00/(72 x serum creatinine (mg/dl)) 4. the coagulation function is adequate, defined as the international normalized ratio (inr) or prothrombin time (pt) ≤ 1.5 times uln; if the subject is receiving anticoagulation therapy, as long as the pt is within the proposed range of anticoagulation drugs * lvef≥50%; * agree and be able to comply with the plan during the research period; * provide written informed consent before entering the study screening, and the patient has understood that participants can withdraw from the study at any time during the study without any loss; exclusion criteria: * complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome; * complicated with severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe renal injury; * received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.; * 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); * uncontrollable pleural effusion, pericardial effusion or ascites; * 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; * allergic reactions to the drugs used in this study; * use steroids or other systemic immunosuppressive therapies 14 days before enrollment; * patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials); * active autoimmune diseases; * history of primary immunodeficiency; * 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 10 mg/day pred nisone or other glucocorticoids in equivalent doses), or use hormones to prevent allergy to contrast agents; * within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccine during the study period; * known to have active tuberculosis; * known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; * hiv antibody positive, active hepatitis b or c (hbv, hcv); * pregnant or lactating women