Perioperative Treatment in Resectable Gastric Cancer with Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): A phase II study (GASPAR)

Resectable Gastric Cancer

The primary endpoint is the proportion of patients with pCR in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist

- Disease-free survival (DFS) defined as time between inclusion and first progression according to RECIST v1.1 criteria or death whatever cause (in the absence of progression); patients without disease progression or death at the time of analysis will be censored at the time of the latest date of assessment, - Overall survival (OS) defined as the time between inclusion and death whatever cause; any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive, - Proportion of patients with margin-free resection (R0), defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed, - Correlation between pCR and DFS, - Correlation between pCR and OS, - Toxicities of the combination Spartalizumab + FLOT regimen according to NCI CTCAE criteria v5.0, - Post-operative morbidity, defined post-operative complications grades II-V according to Clavien-Dindo classification during surgery, within 30 days after surgery or during the hospital stay, - Post-operative mortality, defined as the rate of patients died due to any cause during the 30 days post-surgery

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