Efficacy
DISEASE
In the first stage, eight (88.9%) of the nine patients initially enrolled achieved a pCR, exceeding the threshold required for proceeding to the second stage of enrollment. Among 39 patients finally enrolled, 25 (64.1%, 95%CI: 47.2, 78.8) achieved a pCR (ypT0/Tis ypN0). A total of 35 patients achieved a partial response, and four had stable disease, resulting in an objective response rate of 89.7% (95%CI: 74.8, 96.7) (Fig. 