gastric cancer
Conditions
Interventions
Experimental group:Neoadjuvant XELOX regimen combined with Vedicetuzumab and PD-1 inhibitor will be administered once every 3 weeks (Q3W), tumor response assessment will be performed after 2 or 4 cour
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients enrolled in the study must meet all of the following criteria: 1. Have fully understood the study and voluntarily signed an informed consent form (ICF); 2. Histologically confirmed adenocarcinoma of the stomach or esophagogastric junction was clinically staged at stage II/III based on enhanced CT/MRI, that is, cT1-2N+M0 or cT3-4aNanyM0; 3.HER2 immunohistochemistry 2+ or 3+; 4. Agree to provide previously stored tumor tissue specimens or perform biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1, EBV, MSI immunohistochemical test (IHC) detection; 5. Gender unlimited, age 18-75 years old; 6. General condition is good, ECOG score is 0-1, no contraindications; 7. Physical condition and organ function allow for larger abdominal surgery; 8. Expected survival = 3 months; 9. Laboratory test values within 7 days prior to enrollment must meet the following standards: a.WBC > 4.0×109/L and 1.5×109/L, Hb = 90g/L, PLT = 100×109/L; b. Serum bilirubin = 1.5× normal high limit, AST, ALT = 2.5× normal high limit; c. Creatinine = 1.5× high limit of normal or serum clearance > 60ml/min; D.ivr and aPTT = 1.5 × ULN, only for subjects not receiving anticoagulation therapy; Subjects receiving anticoagulant therapy should be given a steady dose 10. Good compliance, can cooperate with the laboratory, auxiliary inspection and corresponding specimen collection of this program; 11. Fertile women (including those who have had menopause due to chemical menopause or other medical reasons) must consent to the use of contraception for at least five months (whichever is later) from the signing of the informed consent to the final administration of the study treatment or accompanying chemotherapy. Women must also agree not to breastfeed for at least 5 months (mostly later) from the time they sign the informed consent to the last dose of the investigational drug or accompanying chemotherapy; Men must consent to use contraception for at least 7 months (mostly later) from the time of administration of the investigational drug to the time of administration of the investigational drug or accompanying chemotherapy.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions are not allowed to enter this clinical study: 1. Those who are known to be allergic to histidine hydrochloride, mannitol, sucrose, polysorbate 80, sodium hydroxide, monomethyloratin E (test drug components); 2. Previous or current co-occurrence of other malignancies (except 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 during the screening period; 4. Weight loss of more than 20% within 2 weeks during the screening period; 5. Inability to take oral medication; 6. Previous history of chemotherapy, radiotherapy, immunotherapy or surgical treatment for gastric cancer; 7. Previous use of anti-HER2, anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies that act on T-cell co-stimulation or checkpoint pathways); 8. Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment; 9. Patients who require long-term immunosuppressive drug treatment, or who require systemic or local use of immunosuppressive doses (dose > Coorbidities of 10mg/ day prednisone or other isotherapeutic hormones); 10. Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment; 11. Uncontrolled diabetes, hypertension and other systemic diseases; 12. Is receiving or requires anticoagulant therapy (except antiplatelet therapy including low-dose aspirin); 13. The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); Subjects who had vitiligo or had complete remission of asthma in childhood and did not require any intervention as adults could be included; Asthma requiring medical intervention with bronchodilators is not included); 14. Subjects with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to screening; 15. Confirmed history of the following lung diseases based on impact (preferably CT) or clinical findings: interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, acute lung disease; 16. There is contraindication of oxaliplatin or capecitabine use; 17. Pregnant or lactating women or women who may become pregnant; 18.HBsAg positive and HBV DNA copy number positive (quantitative detection =1000cps/ml); 19. Positive results of any of the following tests: human immunodeficiency virus-1 (HIV-1) antibodies, human immunodeficiency virus-2 (HIV-2) antibodies, human T-lymphocytophilic virus-1 (HTLV-1) antibodies, hepatitis C virus (HCV) antibodies; Any other clinically significant disease or condition that the investigator believes may affect protocol adherence or the subject's signing of an informed consent form (ICF), or that makes participation in the clinical trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological reaction;R0 removal rate;Objective tumor response rate;Recurrence-free survival;Overall survival;security; | — |
Countries
China
Contacts
Public ContactQiu Haibo
Sun Yat-sen University Cancer Center
Outcome results
None listed