locally advanced Siewert II/III type of gastro-esophageal junction adenocarcinoma
Conditions
Interventions
Group 1 :Tislelizumab 200 mg ivdrip q3w
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the research and voluntarily signed the informed consent (ICF); 2. Histologically confirmed Siewert type II/III esophagogastric junction adenocarcinoma, clinical stage II/III according to enhanced CT/MRI examination, that is, the stage is cT1-2N+M0 or cT3-4aNanyM0; 3. Agree to provide previously stored tumor tissue samples or perform biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1, EBV, MSIIHC detection; 4. Gender is not limited, age 18-75 years; 5. The general condition is good, the ECOG score is 0-1, and there is no surgical contraindication; 6. Physical condition and visceral function allow for major abdominal surgery; 7. Expected survival period >= 3 months; 8. Laboratory test values ??within 7 days before enrollment must meet the following criteria: (1) WBC > 4.0 x 10^9/L and 1.5 x 10^9/L, Hb >= 90 g/L, PLT>= 100 x 10^9/L; (2) Serum bilirubin 60 ml/min, according to the estimated value of Cockcroft-Gault glomerular filtration rate: (140-age) x (body weight, kg) x (0.85, if female) /72 x (serum creatinine, mg/dL) or: (140-age) x (body weight, kg) x (0.85, if female)/0.818 x (serum creatinine, umol/L); (4) INR and aPTT <= 1.5 x ULN, only applicable to subjects who have not received anticoagulation therapy; subjects receiving anticoagulation therapy should use a stable dose; 9. Good compliance, can cooperate with the laboratory, auxiliary examination and corresponding specimen collection of this plan; 10. Women of childbearing potential (including women with menopause due to chemical menopause or other medical reasons) must agree to be at least 5 months after signing the informed consent form to the last dose of study treatment or concomitant chemotherapy (whichever is later) ) during contraception. Females must also agree not to breastfeed for at least 5 months after the last administration of the study drug or concomitant chemotherapy (whichever is later) from signing the informed consent form to the last administration of the study drug or concomitant chemotherapy; Take contraceptive measures for at least 7 months (mainly later) after the administration of concomitant chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to citric acid monohydrate, sodium citrate dihydrate, mannitol, and polysorbate (components of the test drug); 2. Previously or currently suffering from other malignancies (except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer or any other cancer that has not recurred for at least 5 years) ); 3. Uncontrollable pericardial effusion, pleural effusion or ascites, gastrointestinal bleeding or high risk of bleeding within 2 weeks of enrollment; 4. Weight loss of more than 20% within 2 weeks after enrollment; 5. Unable to take medicine orally; 6. Previous medical history of chemotherapy, radiotherapy, immunotherapy or gastric cancer surgery; 7. Previously used anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway); 8. Received tyrosine kinase inhibitor therapy within 2 weeks before enrollment; 9. Suffering from comorbidities that require long-term immunosuppressive drug therapy, or require systemic or local use of corticosteroids with immunosuppressive doses (dose > 10 mg/day of prednisone or other therapeutic hormones); 10. Have received any anti-infection vaccines (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment; 11. Uncontrolled diabetes, hypertension and other systemic diseases; 12. Are receiving or need anticoagulant therapy (except low-dose aspirin antiplatelet therapy); 13. The subject has any active autoimmune disease or has a history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, thyroid function reduced; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included); 14. Subjects with active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening; 15. According to imaging (preferably CT) or clinical results, there is a history of the following lung diseases: interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, acute lung disease; 16. There are contraindications to the use of oxaliplatin or S-1; 17. Pregnant or lactating women or those who may be pregnant; 18. HBsAg positive and HBV DNA copy number positive (quantitative detection >= 1000 cps/ml); 19. The results of any of the following tests are positive: human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody, human T-lymphotropic virus-1 (HTLV-1) antibody, Hepatitis C virus (HCV) antibodies; 20. Any other clinically significant disease or condition that the investigator believes may affect compliance with the protocol, or affect the subject's signing of the Informed Consent Form (ICF), or is not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response;Even-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete pathological response;tumor regression grade 0/1;R0 resection rate;objective response rate;Relapse-free survival;overall survival;safety; | — |
Countries
China
Contacts
Public ContactChen Yingbo
Sun Yat-sen University Cancer Center
Outcome results
None listed