locally advanced gastric cancer/adenocarcinoma of the esophagogastric junction
Conditions
Interventions
Envolizumab combined with SOX chemotherapy group:Envolizumab
400 mg, subcutaneous injection, d1, Q3W, for 3 cycles
SOX
Tiggio, PO bid D1-14, 40 mg ( body surface area < 1.25 m2 ), 50 mg ( body surface area 1.25-1.5 m2 ), or 60 mg ( body surface area = 1.5 m2)
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent ; 2. Age 18-80 years old ; 3.Histopathological or cytological diagnosis of gastric / gastroesophageal junction adenocarcinoma ; 4.Surgical resection of locally advanced gastroesophageal junction cancer, imaging ( enhanced CT / MRI ) staging of T2-4NanyM0 ; 5.Subjects must provide the tumor tissue at the time of enrollment ( repeated screening subjects do not need to perform PD-L1 detection again ) for PD-L1 expression level determination ; 6.Patients who had not received treatment for locally advanced adenocarcinoma of the gastroesophageal junction ( including chemotherapy, radiotherapy or immunotherapy ) and relapsed more than 6 months after the end of previous adjuvant therapy could be included ; 7.ECOG score : 0 ~ 1 ; 8. Have adequate organ and bone marrow function ; 1 ) Blood routine : Absolute Neutrophil Count ( ANC ) 1.5 × 109 / L, Platelet ( PLT ) = 70 × 109 / L, Hemoglobin ( HGB ) = 90g / L ; 2 ) Liver function : serum total bilirubin ( TBIL ) = 1.5 × upper limit of normal value ( ULN ) ; alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) = 3 × ULN ; serum albumin = 28 g / L ; alkaline Phosphatase ( ALP ) = 5 × ULN ; after routine liver protection treatment, the above criteria were met, and it could be stable for at least 1 week after evaluation by the researchers. 3 ) Renal function : serum creatinine ( Cr ) = 1.5 × ULN, or creatinine clearance rate = 50 mL / mi ( using the standard Cockcroft-Gault formula ) : 4 ) Coagulation function : international normalized ratio ( INR ) = 1.5 / PT = 1.5 × ULN, aPTT = 1.5 × ULN ; if the subject is receiving anticoagulant therapy, as long as PT and INR are within the scope of anticoagulant drugs. 9.Predicted survival = 12 weeks.
Exclusion criteria
Exclusion criteria: 1.There was a history of gastrointestinal perforation or fistula within 6 months before enrollment ; 2.There was a history of gastrointestinal bleeding within 2 months before enrollment, or the risk of gastrointestinal bleeding was judged by the researchers ; 3.Unresectable primary tumor or distant metastasis ; 4.Previous or concurrent with other malignant tumors ; 5.Patients who have previously received systemic immunotherapy ; 6.Known subjects ' previous allergies to macromolecular protein preparations or applied drug components ; 7.Active autoimmune diseases requiring systemic treatment ( such as the use of disease-relieving drugs, glucocorticoids or immunosuppressive agents ) occurred within 2 years before the first administration. Replacement therapy ( e.g. thyroxine, insulin or physiologic glucocorticoids for adrenal or pituitary insufficiency ) is not considered systemic ; 8. The study is being treated with systemic corticosteroids ( excluding intranasal, inhalant or other topical corticosteroids ) or any other form of immunosuppressive therapy within 7 days prior to the first administration ; note : Physiological doses of glucocorticoids ( = 50 mg / day of hydrocortisone or equivalent ) are allowed ; 9.Subjects were still using traditional Chinese medicine or other immunomodulators within 2 weeks before enrollment ; 10. clinical symptoms of ascites or pleural effusion, can not be controlled with drugs, the need for therapeutic puncture or drainage ; 11.There are clinical symptoms or diseases of the heart that are not well controlled, such as : 1 ) Heart failure above NYHA grade 2 ; 2 ) unstable angina pectoris ; 3 ) Myocardial infarction occurred within 1 year ; 4 ) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention ; 12.Subjects were known to have a history of psychotropic drug abuse, alcoholism or drug abuse ; 13. Women during pregnancy or lactation ; 14.Men with reproductive ability or women with the possibility of pregnancy ( men or women who have not undergone birth control surgery, and women without menopause ) must use highly effective contraceptive methods during the trial ( such as oral contraceptives, intrauterine contraceptives, abstinence or barrier contraceptives combined with spermicides ), and continue contraception for 6 months after the last administration ; 15. The researcher believes that it should be excluded from this study, for example, if the researcher determines that the subject has other factors that may lead to the forced termination of this study, such as other serious diseases ( including mental illness ) that require combined treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of Main pathological remission;Rate of R0 resection;disease-free survival;objective remission rate;overall survival; | — |
Countries
China
Contacts
Public ContactWeiming Kang
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed