Gastric Cancer
Conditions
Interventions
Experimental group:SOX combined with PD-1(TNAC)+ D2 lymph node dissection
Control group:SOX(NAC)+ D2 lymph node dissection+ SOX
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. Fully informed about the study and voluntarily sign an informed consent form (ICF); 2. Histologically CT/MRI confirmed cT3-4aN+M0 gastric adenocarcinoma; 3. Consent to send previously-stored tumor tissue or perform a biopsy to collect tumor lesion tissues for PD-L1, and MSI immunohistochemistry (IHC) detection at the center’s laboratory of Department of Pathology, Cancer Prevention and Treatment Center, Sun Yat sen University; 4. Men or women, 18-75 years; 5. Good general condition with ECOG 0-1, and without surgery contraindications; 6. Physical condition and adequate organ function to ensure the completion of abdominal surgery; 7. Expected survival = 3 months; 8. Laboratory values must meet the following criteria within 7 days prior to enrollment: a. WBC > 4.0 × 10^9/L and 1.5 × 10^9/L, Hb = 90 g/L, PLT = 100 × 10^9/L; b. Serum bilirubin = 1.5 × upper limit of normal, AST and ALT = 2.5 × upper limit of normal; c. Creatinine = 1.5 × upper limit of normal or serum clearance > 60 ml/min, based on the estimated glomerular filtration rate by Cockcroft-Gault: (140 - age) × (weight in kg) × (0.85 if female) / 72 × (serum creatinine, mg/dl) or: (140 - age) × (weight in kg) × (0.85 if female) / 0.818 × (serum creatinine, µmol/l) d. INR and aPTT = 1.5 × ULN only for subjects not receiving anticoagulant therapy; Subjects receiving anticoagulant therapy should be administrated at a stable dose 9. Have good compliance, and cooperate with the laboratory, auxiliary examination and corresponding specimen collection specified in this protocol; 10. Females of childbearing potential (including those who are chemically or medically postmenopausal) must agree to use contraception from signing the informed consent until at least 5 months after the last study treatment or concomitant chemotherapy (whichever is later). Such females should also agree to not breastfeed from signing the informed consent until at least 5 months after the last study treatment or concomitant chemotherapy (whichever is later); Males should agree to use contraception from the time of administration of investigational drug until at least 7 months after the administration of the investigational drug or concomitant chemotherapy (whichever is later).
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this clinical study: 1. Known allergy to citric acid monohydrate, sodium citrate dihydrate, mannitol, and polysorbate (components of the investigational drug); 2. Previous or concurrent other malignancies (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer or any other malignancies that have not recurred for at least 5 years); 3. Uncontrolled pericardial effusion, pleural effusion or ascites, hemorrhage of the digestive tract, or high risk of hemorrhage in 2 weeks before recruitment; 4. Weight loss > 20% within 2 weeks before recruitment; 5. Unable to swallow the study drug; 6. Having a history of chemotherapy, radiotherapy, immunotherapy or surgical treatment for gastric cancer; 7. Prior therapy with PD-1 inhibitors, PD-L1 inhibitors, PD-L2 inhibitors, or CTLA-4 inhibitors (or other inhibitors in T cell co-stimulatory signals or checkpoint pathways); 8. Prior therapy with tyrosine kinase inhibitor within 2 weeks; 9. Concurrent medical condition requiring chronic therapy with immunosuppressive drugs, or systemic or topical corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or equivalent dose of the similar drugs); 10. Have vaccination with any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine) within 4 weeks prior to enrollment; 11. Uncontrolled diabetes, hypertension and other systemic diseases; 12. Receiving or requiring anticoagulant therapy (except antiplatelet therapy with low-dose aspirin); 13. With any active autoimmune diseases or history of autoimmune diseases (including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or who had a complete response of asthma in childhood and do not require any intervention in adulthood can be included; who has the asthma requiring medical intervention with a bronchodilator cannot be included); 14. Patients with active tuberculosis (TB) who are receiving antituberculosis therapy or have received anti-tuberculosis therapy within 1 year prior to screening; 15. With histories of the following lung diseases confirmed by imaging (preferably CT) or clinical findings: interstitial pneumonia, noninfectious pneumonitis, pulmonary fibrosis, acute lung disease; 16. Contraindication to oxaliplatin or capecitabine or tegafur/gimeracil/oteracil; 17. Pregnant or lactating women or those who may become pregnant; 18. Positive test for HbsAg and HBV-DNA copy numbers (= 1000 cps/ml); 19. Positive results for any of the following tests: human immunodeficiency virus-1 (HIV-1) antibodies, human immunodeficiency virus-2 (HIV-2) antibodies, human T-cell lymphotropic virus 1 (HTLV-1) antibodies, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies; 20. Any other disease or condition that, in the opinion of the investigator, may affect the compliance or the signing of the informed consent form (ICF), or is inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of TRG 0/1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of pCR;EFS;ORR;OS; | — |
Countries
China
Contacts
Public ContactHaibo Qiu
Sun Yat-Sen University Cancer Center
Outcome results
None listed