Endpoints and response assessment and toxicity
tumor, Tumor, Cancer
ADVERSE EVENT, TUMOR, TUMOR, ADVERSE EVENT, EVENTS, CANCER
The primary endpoints were safety and feasibility. Secondary endpoints were pCR, OS, RFS and R0 rates. Tumor assessment was carried out every 6 weeks, and the tumor response was evaluated according to RECIST 1.1 guidelines after blinded central review. Adverse events were assessed in all patients who had received at least two doses of the treatment; these events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v.5.0.