gastric cancer
Conditions
Interventions
Experimental group:Drug: oxaliplatin+Docetaxel+Tiggio + Tislelizumab
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed an informed consent form (ICF); 2. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert II-III); 3. Clinical stage: cT3N+M0/cT4NxM0 (AJCC 8th edition) 4. Gender unlimited, age 18-80 years old; 5. Generally in good condition, ECOG score is 0-1; 6. The organ function allows for large abdominal surgery; 7. Expected survival =6 months; 8. Laboratory test values within 7 days prior to enrollment must meet the following standards: (1)WBC > 4.0×10^9/L and 1.5×10^9/L, Hb = 75g/L, PLT = 100×10^9/L; (2) Serum bilirubin = 1.5× normal high limit, AST, ALT = 2.5× normal high limit; (3) Creatinine = 1.5× high limit of normal value or serum clearance > 60ml/min; (4)INR and aPTT = 1.5 × ULN, applicable only to subjects not receiving anticoagulation therapy; Subjects receiving anticoagulant therapy should be given a steady dose; 9. Good compliance, can cooperate with the laboratory, auxiliary inspection and corresponding specimen collection of this program; 10. No surgery or chemotherapy was performed before diagnosis.
Exclusion criteria
Exclusion criteria: 1.Other active malignancies within 5 years or at the same time. Cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ can be included in the group; 2. Patients who are preparing for or have previously received organ or bone marrow transplants; 3. Myocardial infarction or poorly controlled arrhythmia occurred within 6 months before the first medication; 4. The presence of NYHA standard grade ? ~ ? cardiac insufficiency or heart color ultrasonography: LVEF (left ventricular ejection fraction) 10 mg/ day efficacy dose of prednisone) or other immunosuppressive agents within 14 days prior to first administration or during the study period. However, in the absence of active autoimmune disease, patients were allowed to use topical or inhaled steroids, or adrenal hormone replacement at a therapeutic dose of 10mg/ day or less with prednisone; 11. Any active infection that requires systematic anti-infective therapy occurs within 14 days prior to the first dose; 12. Previously received other antibody/drug therapy targeting immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.; 13. Is being treated in other clinical studies; 14. Known history of severe allergy to any monoclonal antibody or investigational drug excipients, oxaliplatin, Teghio, docetaxel; 15. Known history of psychotropic substance abuse or drug use; Patients who had stopped drinking alcohol could be enrolled; 16. Patients who have an increased risk of study participation and investigational medication, or other severe, acute, or chronic medical conditions that the investigator determines are not suitable for clinical study participation. 17. Known tendency of gastrointestinal bleeding; 18. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathologic complete response;Disease control rate;Objective Response Rate;R0 resection rate;overall survival;Postoperative Complications; | — |
Countries
China
Contacts
Public ContactXi Chen
Anhui Provincial Cancer Hospital
Outcome results
None listed