Tumor regression grade (TRG)
Time frame · within 10 days after surgery
Tumor regression grade was determined according to the postoperative pathological results.
Pathologic complete response (pCR) rate
Time frame · within 10 days after surgery
Defined as the proportion of patients in the ITT population who reach pT0N0M0 among patients undergoing surgery.
Median progression-free survival (mPFS)
Time frame · 24 months
The median time from the first dose to any documented tumor progression or death due to any cause (whichever occurs first) in the ITT population. Patients who are alive at the time of analysis and have no documented disease progression will be reviewed on the date of the last imaging assessment.
Median overall survival (mOS)
Time frame · 24 months
The median time from the first dose to death due to any cause in the ITT population. Patients who are alive at the time of analysis will be reviewed on their last contact date.
Major pathologic response (MPR) rate
Time frame · within 10 days after surgery
Defined as the proportion of patients in the ITT population who achieve TRG1 among patients undergoing surgery.
Objective response rate (ORR)
Time frame · Baseline (before surgery)
Defined as the proportion of patients in the ITT population achieving complete response (CR) + partial response (PR) according to iRECIST.
Disease control rate (DCR)
Time frame · Baseline (before surgery)
Defined as the proportion of subjects in the ITT population who achieve disease response and stable disease among all subjects.
TRAE
Time frame · from commencing of treatment to the 30th day after surgery
Incidence of treatment-related adverse event
irAE
Time frame · from commencing of PD-1 inhibitor to the 30th day after surgery
Incidence of immune-related adverse event
Incidence of surgical complications
Time frame · within 30 days after surgery
Incidence of surgical complications within 30 days after surgery