Endpoints and assessments
toxicity, tumor
TUMOR, ADVERSE EVENT, PRIMARY TUMOR, PATHOLOGY, COMPLICATIONS
The primary endpoint was the MPR (i.e., ≤ 10% viable tumor cells in the primary tumor at resection based on a BIPR). The MPR was evaluated locally according to standard operating procedure and study-specific pathology training.Secondary endpoints included the MPR according to PD-L1 expression levels, investigator-assessed ORR based on RECIST, pCR (i.e., no residual viable tumor cells in the primary tumor and sampled lymph nodes based on BIPR), pathological lymph node downgrade rate, EFS, OS, and treatment toxicity and surgery feasibility measured by the incidence of immune-related adverse event. Indicators for surgery feasibility included the completeness of resection, operative approach and type, mortality, morbidity, and complications within the first 90 days following the surgery. Treatment toxicity was evaluated for 100 days following the last dose of adjuvant nivolumab or neoadjuvant, based on NCI-CTCAE (version 4.0) guidelines.