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Progression-Free-Survival (PFS)
OS is the length of time from the date of inclusion until death from any cause.
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations