gastric, or gastro-esophageal junction cancer
Conditions
Interventions
treatment group:oxaliplatin 130mg/m^2 ivdrip d1 q3w
treatment group:tegafur 40mg/m^2 bid po d1-14 q3w
treatment group:Trastuzumab 8mg/kg for the frist time,6mg/kg from the second time ivdrip q3w
treatment group:Sintilimab 200mg ivdrip q3w
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the study and voluntarily sign the Informed Consent Form (ICF); 2. Adenocarcinoma at the junction of stomach/esophagus and stomach diagnosed histologically shall be clinically classified as stage II/III according to enhanced CT/MRI examination, that is, cT1-2N+M0 or cT3-4aNanyM0; 3. Immunohistochemical HER2 3+or HER2 2+and FISH test positive; 4. Agree to provide previously stored tumor tissue samples or conduct biopsy to collect tumor focus tissue and send it to the central laboratory for PD-L1, EBV, MSI IHC detection; 5. No gender limit, aged 18-80 years; 6. It is generally in good condition, with an ECOG score of 0-1 and no surgical contraindication; 7. The physical condition and organ function are allowed to undergo major abdominal surgery; 8. Expected life >= 3 months; 9. Laboratory inspection values within 7 days before enrollment must meet the following standards: 1). WBC > 4.0 × 10 ^ 9/L and 1.5 × 10^9/L, Hb >= 90g/L, PLT >= 100 × 10^9/L 2). Serum bilirubin 60ml/min, according to the estimated value of Cockcroft Gault glomerular filtration rate: [(140 - Age) × (Weight, kg) × (0.85 if female)]/[72 × (Serum creatinine, mg/dL)] Or: [(140 - Age) × (Weight, kg) × (0.85 if female)]/[0.818 × (Serum creatinine, umol/L)] 4). INR and aPTT <= 1.5 × ULN, only applicable to subjects not receiving anticoagulation treatment; The subjects receiving anticoagulation treatment should use a stable dose 10. Good compliance, which can cooperate with the laboratory, auxiliary inspection and corresponding sample collection of this scheme; 11. Women with fertility (including women who have menopause due to chemical menopause or other medical reasons) must agree to take contraceptive measures at least 5 months (whichever is later) from signing the informed consent form to the last administration of research treatment or chemotherapy. Women must also agree not to breastfeed at least 5 months (mainly later) from the signing of the informed consent form to the last administration of the study drug or concomitant chemotherapy; The male must agree at least 7 months (whichever is later) after the administration of the investigational drug to the investigational drug or concomitant chemotherapy Take contraceptive measures during).
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbate (components of the test drug); 2. Previous or present patients with other malignant tumors (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer carcinoma or any other cancer that has not recurred for at least 5 years); 3. Uncontrolled pericardial effusion, pleural effusion or ascites, gastrointestinal bleeding or high risk of bleeding within 2 weeks after enrollment; 4. Weight loss of more than 20% within 2 weeks after enrollment; 5. The drug cannot be taken orally; 6. Have a history of chemotherapy, radiotherapy, immunotherapy or gastric cancer surgery; 7. Have used anti HER2, anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4 antibody in the past (or any other antibody acting on T cell co stimulation or checkpoint passage); 8. He received tyrosine kinase inhibitor treatment within 2 weeks before enrollment; 9. Suffering from complications that require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects (dose > 10mg/day of prednisone or other effective hormones); 10. Have been vaccinated with any anti infection vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment; 11. Uncontrolled systemic diseases such as diabetes and hypertension; 12. The patient is receiving or needs anticoagulant treatment (except for the antiplatelet treatment of low-dose aspirin); 13. Subjects have any active autoimmune diseases or have a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood has completely alleviated, and do not need any intervention after adulthood can be included; subjects with asthma requiring medical intervention of bronchodilators cannot be included); 14. Subjects with active pulmonary tuberculosis (TB) are receiving anti tuberculosis treatment or have received anti tuberculosis treatment within 1 year before screening; 15. According to the imaging (preferably CT) or clinical results, the following lung diseases were confirmed: interstitial pneumonia, non infectious pneumonia, pulmonary fibrosis, and acute lung disease; 16. There is a taboo to use oxaliplatin or tegeol; 17. Pregnant or lactating women or those who may be pregnant; 18. HBsAg is positive and HBV DNA copy number is positive (quantitative detection >= 1000cps/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) antibody; 20. Any other disease or condition of clinical significance that the investigator thinks may affect the compliance of the protocol, or affect the subject to sign the Informed Consent Form (ICF), or is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete pathological response, pCR;tumor regression grade 0/1, TRG 0/1;objective response rate, ORR;relapse-free survival, RFS;overall survival, OS;Safety;Even-free survival; | — |
Countries
China
Contacts
Public ContactYuanfang Li
Sun Yat-Sen University Cancer Center
Outcome results
None listed