Endpoints
tumor, death, TRAEs, TEAEs
TUMOR, RECURRENCE, COMPLICATIONS, RESIDUAL TUMOR
The primary endpoint was the pCR rate, i.e., the absence of viable residual tumor cells in the resected specimen. Secondary endpoints included major pathological response (MPR, i.e., residual tumor cells below 10% in the resected specimen), R0 resection rate (i.e., complete removal of the tumor with a tumor-free margin), DFS, EFS, and OS. DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence. EFS was the time from enrollment to recurrence or death from any cause. EFS was censored on the last tumor assessment date for patients still alive and without recurrence. OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death. Safety endpoints included TEAEs, TRAEs, irAEs, and surgical AEs (i.e., complications occurring during or within 30 days of surgery).