Endpoints
toxicity, Tumors
ADVERSE EVENTS, DISEASE, TUMORS, PROGRESSION, SECONDARY, COMPLICATIONS
The primary endpoint is the 1-year PFS rate, and the secondary endpoints are the PFS, DFS, OS, 1-year PFS rate by central image review, ORR, pathological complete response (CR) rate of distant metastatic lesions and the primary lesion as assessed by pathologists at each institution, protocol treatment completion rate, R0 resection rate, incidence of adverse events, and incidence of surgery-related complications. An exploratory endpoint is the analysis of biomarkers related to the efficacy and toxicity of the protocol treatment. Progression is defined as either progressive disease based on diagnostic imaging in the assessment of overall response according to the revised guidelines on the Response Evaluation Criteria in Solid Tumors version 1.1 [