gastric cancer
Conditions
Interventions
Test group:Enwollizumab+NSOX
Sponsors
First affiliated hospital of Soochow university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent prior to the implementation of any test related procedures; 2. Male or female, above 18 years old; 3. Patients diagnosed with gastric adenocarcinoma by biopsy and histopathological examination of the primary lesion; Patients (cT2-4, N1-3M0) with stage II-IVA who were judged by imaging and gastroscopy as operable and requiring neoadjuvant therapy; 4. Imaging and gastroscopy indicated that the tumor was mainly located in the stomach. 5. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there was at least one radiographically measurable lesion; The patient had not received any antitumor therapy in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. 6.ECOG score 0-1; 7. Adequate organ function, subject shall meet the following laboratory criteria: 8. In the past 14 days without the use of granulocyte colony stimulating factor, the absolute value of neutrophil granulocyte (ANC) =1.5x109/L. 9. Platelets =100×109/L without blood transfusion in the past 14 days. 10. Hemoglobin > in the absence of blood transfusion or use of erythropoietin within the last 14 days; 9g/dL; Total bilirubin =1.5× upper limit of normal value (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =2.5×ULN, serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcrod-Gault formula) =60 ml/min; 11. Good coagulation function, defined as International Standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; 12. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range; 13. The myocardial enzyme profile was within the normal range (simple laboratory abnormalities with no clinical significance were also allowed to be included). 14. For female subjects of childbearing age, urine or serum pregnancy tests should be conducted and the results are negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 15. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignancies and not cured within 5 years prior to initial administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous epithelial carcinoma, and/or carcinoma in situ after radical excision); 2. Patients at risk of tracheoesophageal fistula or aortoesophageal fistula; 3. Currently participating in an interventional clinical study, or receiving other investigational drugs or using investigational devices within 4 weeks prior to initial dosing; 4. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137); 5. Received systemic systemic therapy with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs within 2 weeks before the first administration; 6. An active autoimmune immune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 7. Was receiving systemic glucocorticoid therapy (excluding nasal, inhalation, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: Physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) are permitted; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Those who are known to be allergic to the active ingredients or excipients of the drug in this study and the drug combined with chemotherapy; 10. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair loss); 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive coupled with a detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load < before initial administration; At 1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study chemotherapy regimen 2) For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection); 14. Received live vaccine within 30 days prior to initial administration (cycle 1, day 1); Note: Inactivated injectable virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; But live attenuated influenza vaccines administered intranasally are not allowed. 15. Pregnant or lactating women; 16. There is any serious or uncontrolled systemic disease, such as: 1) The resting electrocardiogram (ECG) presents significant and severely uncontrollable abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, ? degree or above heart block, ventricular arrhythmia o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;relapse free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWei Li
First Affiliated Hospital of Soochow University
Outcome results
None listed