gastric or gastro-esophageal junction adenocarcinoma
Conditions
Interventions
treatment group:Sintilimab ivdrip 200mg q3w
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The enrolled patients must meet all of the following criteria for inclusion as follows: 1. Have fully understood the study and voluntarily signed the informed consent (ICF); 2. Have a histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma, clinically staged as II/III based on enhanced CT/MRI examination, corresponding to cT1-2N+M0 or cT3-4aNanyM0; 3. Have a histologically confirmed diagnosis of gastric adenocarcinoma and have been determined to be dMMR or MSI-H through immunohistochemistry or PCR, or PDL1 (22C3) CPS = 10 through immunohistochemistry; 4. No gender limit, aged 18-75 years; 5. General condition is good, ECOG score is 0-1, no contraindications to surgery; 6. Have a physical status and organ function that allow him/her to undergo major abdominal surgery; 7. Expected survival >= 3 months; 8. Laboratory test values within 7 days prior to enrollment must meet the following standards: (1) WBC > 4.0x10^9/L and 1.5x10^9/L, Hb >= 90g/L, PLT >= 100x10^9/L; (2) Serum bilirubin 60ml/min, estimated by 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, µmol/L) D.NR and aPTT <= 1.5 x ULN, only for subjects not receiving anticoagulant therapy; Subjects receiving anticoagulant therapy should receive a steady dose; 9. Good compliance with the ability to cooperate with the laboratory, auxiliary inspection and corresponding specimen collection of this study; 10. Fertile women (including those who have undergone menopause due to chemical menopause or other medical reasons) must consent to the use of contraception for a period of at least five months (whichever is later) from the signing of the informed consent to the study treatment or the final administration of the accompanying chemotherapy. Women must also agree not to breastfeed for at least five months (whichever is later) from the time they sign the informed consent to the last dose of the study drug or accompanying chemotherapy; Men must consent to use contraception for at least 7 months (whichever is 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: Patients who meet any of the following criteria shall not be eligible to participate in this clinical study: 1. Known allergies to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbate (components of the investigational drug); 2. With a history of concurrent or current malignancies (except for completely excised basal cell carcinoma, stage I squamous cell carcinoma, in situ carcinoma, mucosal 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 of enrollment; 5. Inability to take medications orally; 6. Previous history of chemotherapy, radiotherapy, immunotherapy or surgical treatment for gastric cancer; 7. Previous use of 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 costimulation or checkpoint pathways); 8. Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment; 9. Patients with complications requiring long-term immunosuppressive drug therapy or systemic or local use of corticosteroids with immunosuppressive doses (doses > 10mg/ day of prednisone or other therapeutic hormones); 10. Received any anti-infective vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment; 11. Uncontrolled diabetes, hypertension and other systemic diseases; 12. Receiving or requiring anticoagulant therapy (other than antiplatelet therapy including low-dose aspirin); 13. Have any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Patients who had vitiligo or had complete remission of asthma in childhood and did not need any intervention as adults were enrolled; Asthma requiring medical intervention with bronchodilators is not included); 14. Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year prior to screening; 15. A history of the following lung diseases confirmed by impact (preferably CT) or clinical findings: interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, acute lung disease; 16. There are contraindications in the use of oxaliplatin or Tiggio; 17. Pregnant or lactating patients or patients who may become pregnant; 18. Positive results of any of the following tests: 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; 19. Any other disease or condition of clinical significance that the investigator believes may affect protocol compliance, or may affect the patient's signing of an informed consent form (ICF), or may preclude participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor regression grade 0/1, TRG 0/1; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete pathological response, pCR;major pathological response, MPR;R0 resection rate;objective response rate, ORR;event free survival, EFS;recurrence free survival, RFS;overall survival, OS;safety; | — |
Countries
China
Contacts
Public ContactLi Yuanfang
Sun Yat-sen University Cancer Center
Outcome results
None listed