gastric cancer
Conditions
Interventions
treatment group:The standard dose of sindilizumab 200mg+SOX regimen was given for 3 courses of treatment before surgery
The standard dose of sindilizumab +SOX regimen was treated for 5 courses after o
control group:The standard dose of SOX regimen was given for 3 courses before operation
SOX regimen was given for 5 courses after operation
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 2. Male or female, =18 years old, 9g/dL in the last 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin =1.5× upper limit of normal (ULN); Total bilirubin > 1.5xULN but direct bilirubin =ULN were also allowed. 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are =2.5×ULN 6) Serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min; 7) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included); 9. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period. 10. Subjects (or their legal representative/guardian) must sign an informed consent indicating that they understand the purpose of the study, understand the necessary procedures, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. malignant diseases other than gastric cancer (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radical resection of carcinoma in situ) diagnosed within 5 years prior to initial administration; 2. Known endoscopic signs of active bleeding; 3. Is currently participating in an interventional clinical study, or has received other investigational drugs or used 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 respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 5. Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration; 6. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement 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 topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) is permitted; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Known allergy to the drugs used in this study; 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 and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load <1000 copies /ml (200 IU/ml) prior to initial dosing, subjects should receive anti-HBV therapy throughout study chemotherapy therapy to avoid viral reactivation 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 levels above the lower limit of detection); 14. Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted 15. Pregnant or lactating women; 16. The presence of any serious or uncontrolled systemic disease, such as: 1) The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above ? degree, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactYu Pengfei
Zhejiang Cancer Hospital
Outcome results
None listed