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Table 1 Eligibility criteria

From: Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): a phase II study (GASPAR)

Inclusion criteria

Non-inclusion criteria

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