locally advanced gastroesophageal junction(GEJ) adenocarcinoma
Conditions
Interventions
treatment group:preoperative Tislelizumab plus chemoradiotherapy
Sponsors
LIAONING CANCER HOSPITAL & INSTITUTE
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign informed consent form 2) Aged >= 18 , =1 tested by the central laboratory 7) Clinical staging at visit: T3-4aN+M0 determined by the 8th edition AJCC staging system -Esophageal gastric duodenal endoscopy is necessary -Suggest performing endoscopic ultrasound examination 8) Physical conditions and organ functions permit the appropriate surgical treatment 9) The physical status of the Eastern tumor collaboration group (ECOG) was 0 or 1 10) Expected survival >=6 months 11) The disease did not progress after receiving sequential chemoradiotherapy 12) The following laboratory test results obtained within 7 days prior to the start of research treatment are defined as having sufficient hematological and organ functions a. Hematology (no blood components or cell growth factors were used to support treatment within 7 days prior to the start of the study): i. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (1500/mm3); Ii. Platelet count >= 100 × 10^9/L (100000/mm3); Iii. Hemoglobin >= 90g/L; b. Kidney: i. Blood creatinine = 50 mL/min *The Cockcroft Fault formula will be used to calculate CrCl CrCL (mL/min)={(140 age) x body weight (kg) x F}/(SCr (mg/dL) x 72) Among them, F=1 for males and F=0.85 for females; SCR=serum creatinine c. Liver: i. Total serum bilirubin (TBiL)= 28 g/L; d. Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT) = 50%; 13) Women of childbearing age must undergo a serum pregnancy test within 7 days prior to randomization, with a negative result, and agree to use reliable and effective contraception methods during the trial period and within 5 months after the last dose. For male participants whose partners are women of childbearing age, they must agree to use reliable and effective methods of contraception during the trial period and within 5 months after the last dose. Breastfeeding women are not eligible for enrollment.
Exclusion criteria
Exclusion criteria: 1) Stage IV (metastatic) or gastric cancer/GEJ cancer that cannot be surgically removed as determined by the researcher 2) Previously received non-surgical treatment for gastric cancer (such as radiotherapy, chemotherapy, and immunotherapy) 3) Screening for malignant tumors with a history other than GC within the first 5 years, but with a negligible risk of metastasis or death (such as a 5-year OS rate>90%), excluding malignant tumors such as fully treated cervical carcinoma in situ, non melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I cervical cancer 4) At the time of enrollment, there was cardiopulmonary dysfunction, defined by any of the following: a) Any classification of congestive heart failure b) Angina requiring treatment with anti angina drugs, severe arrhythmia that cannot be controlled by appropriate medication, severe conduction abnormalities, or clinically significant valve diseases c) High risk, uncontrolled arrhythmias (i.e. atrial tachycardia with resting heart rate>100 beats per minute, significant ventricular arrhythmias (ventricular tachycardia), or high degree atrioventricular block (type 2 atrioventricular block) or third degree atrioventricular block) d) Obvious symptoms related to left ventricular dysfunction, cardiac arrhythmia, or myocardial ischemia (level >= 2) e) Myocardial infarction within the first 12 months of randomization f) Uncontrolled hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg) g) Evidence of transmural myocardial infarction on ECG h) Oxygen therapy is required i) Difficulty breathing at rest 5) Active or history of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wagner's granuloma, Schering's syndrome, Guillain Barre syndrome, or multiple sclerosis (more detailed list of autoimmune diseases and immunodeficiency can be found in the protocol), except for the following: patients with a history of autoimmune hypothyroidism and undergoing thyroid replacement hormone therapy can participate in this study. a) Patients with controlled type 1 diabetes who received insulin regimen can participate in this study. b) Patients with eczema, psoriasis, chronic simple lichen, or vitiligo with only skin manifestations (e.g. excluding patients with psoriatic arthritis) are eligible to participate in this study if all of the following conditions are met. The skin rash must cover a surface area of<10% - The disease is well controlled at baseline, requiring only low-intensity topical corticosteroids There have been no acute exacerbations of underlying diseases requiring psoralen plus ultraviolet A radiation, methotrexate, retinoic acid, biologics, oral calcineurin inhibitors, or high-intensity or oral corticosteroids in the past 12 months. 6) Patients with idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, history of idiopathic pneumonia, or screening chest CT scans showing evidence of active pneumonia, and a history of radiation pneumonia (fibrosis) in the radiation field, may participate in this study. 7) Active pulmonary tuberculosis 8) Major surgery other than diagnostic purposes was performed within 4 weeks prior to the start of the study treatment, or it is expected that major surgery wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;major pathological response rate;objective response rate;R0 resection rate;overall survival rate; | — |
Countries
China
Contacts
Public ContactZhang Tao
LIAONING CANCER HOSPITAL & INSTITUTE
Outcome results
None listed