Gastric cancer/Gastroesophageal junction adenocarcinoma
Conditions
Interventions
Intervention group:Tislelizumab+SOX
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study, be able to complete the signing of the informed consent form, and have good compliance; 2. Gender is not limited, age > = 18 years and = 6 months; 5. HER-2 negative; 6. The tumor was detected by the central laboratory to express PD-L1, and the tumor proportion score (CPS) was >=1; 7. Histological and imaging examinations assessed as advanced gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma, with a clinical stage of cT3-T4aN+M0; 8. Evaluation by the attending physician prior to enrollment to determine the study eligibility to perform R0 resection with curative intent; 9. Good heart function. Patients with underlying ischemic, valvular heart disease, or other serious cardiac disease should be evaluated preoperatively by a cardiologist if clinically indicated; 10. No cytotoxic or targeted therapy in the past, no partial or complete esophagogastric tumor resection in the past; 11. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) is required=90g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelets (PLT) >=80×10^9/L; Biochemical tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 mL/min; 1) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =50%; 3) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; Clinically judged by physicians to have adequate organ function. 14. Subjects of childbearing potential must use an appropriate method of contraception, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects during the study and for 120 days after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Have had or simultaneously have other active malignant tumors within 5 years. Cured localized tumors, as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast in situ, are eligible; 2. Patients who are preparing for or have previously undergone organ or bone marrow transplantation; 3. Have >=2 grade myocardial ischem or myocardial infarction, arrhythmia (QTc >=470ms), and >=2 grade congestive heart failure (New York Heart AssociationNYHA] classification); 4. Human immunodeficiency virus (HIV) infection; 5. Have active pulmonary tuberculosis; 6. Have a history or current presence interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary dysfunction, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity; 7. Have known active or suspected autoimmune diseases, except those in a stable state at the time of enrollment (not requiring systemic immunospressive therapy); 8. Have received live vaccine treatment within 28 days before the first dose; seasonal flu vaccines are not included; 9. Have received or need receive systemic corticosteroids (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days before the dose or during the study. However, the following cases are allowed: patients with no active autoimmune diseases can use topical or inhaled corticosteroids, or hormone replacement therapy with a dose <= 10 mg/day prednisone equivalent dose; 10. Any active infection requiring systemic anti-infective therapy within 14 days prior to the first dose; Except for prophylactic antibiotic therapy (e.g., prophylaxis of urinary tract infection or chronic obstructive pulmonary disease); 11. Have previously received other antibodies/drugs targeting immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.; 12. Are currently receiving other clinical study treatments, or the time between the end of the previous clinical study treatment and the planned start of this study treatment is less than14 days; 13. Have a known severe allergic history to any monoclonal antibody or excipients of the study drug; 14. Have a history of psychiatric drug abuse or drug addiction; patients who have stopped drinking alcohol can be enrolled; 15.According to the investigator's judgment, patients with serious concomitant that endanger the safety of the subjects or affect the completion of the study, or patients who are deemed unsuitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 21/2000 Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Major pathological remission; | — |
Countries
China
Contacts
Public ContactZheng Zhichao
Liaoning Cancer Hospital & Institute
Outcome results
None listed