Inclusion criteria | Non-inclusion criteria |
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● Patient ≥ 18 years at the day of consenting to the study ● Provision of informed consent prior to any study specific procedures ● Untreated localized gastric or GEJ adenocarcinoma considered resectable (clinical stage ≥ cT2 and/or cN + and no metastasis) ● Histologically confirmed adenocarcinoma ● ECOG performance status score ≤ 1 ● Tumor tissue must be provided for biomarker analyses (fresh or archival with an FFPE tissue block) ● All subjects must consent to allow the acquisition of blood samples for performance of correlative studies ● Screening laboratory values must meet the following criteria: WBC ≥ 2000/ mm3, Neutrophils ≥ 1500/ mm3, Platelets ≥ 100 000/ mm3, Hemoglobin ≥ 9.0 g/dL, Bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN, measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula), Potassium ≥ LLN, Magnesium ≥ LLN and Calcium ≥ LLN ● Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72 h before study start ● Subject in reproductive age must be willing to use adequate contraception during the study and at least 9 months in men and 12 months in women after the last dose of investigational drug. In addition, given the toxicities observed on the male reproductive system, a conservation of gametes will be proposed for men ● Subject affiliated to a social security regimen | ● Subject with any distant metastasis ● Subject with no recovering from the effects of major surgery or significant traumatic injury within 14 days before inclusion ● Documented significant cardiovascular disease within the past 6 months before the first dose of study treatment, including: history of congestive heart failure (defined as NYHA III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis ● History of anterior organ transplant ● Pneumonitis or interstitial lung disease ● History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma) ● Active, known, or suspected autoimmune disease ● Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment ● Known history of HIV or HBV infection, history of active tuberculosis, active HCV infection ● Vaccination with live vaccine within 30 days before the first dose of study treatment ● Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways ● Recent or concomitant treatment with brivudine ● Prior anticancer therapy for the current malignancy ● Known hypersensitivity to any of the study drugs or their excipients ● Chronic inflammable gastro-intestinal disease ● Uracilemia ≥ 16 ng/ml ● QT/QTc > 450 ms for men and > 470 ms for women ● Peripheral neuropathy ≥ Grade II ● Uncontrolled diabetes ● Active infection requiring systemic therapy ● Participation in another therapeutic clinical study ● Patient deprived of liberty or placed under the authority of a tutor ● Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol |