Outcomes and assessments
PD, death
TUMOR RECURRENCE
The primary endpoint of this trial was ORR, including complete and partial responses as determined by the investigator and independent post hoc analysis. Secondary endpoints included OS (dated from the first treatment with study medication to the date of death owing to any cause or censored on the date of last follow-up), PFS (dated from the first treatment with study medication to the first documented PD or death owing to any cause, whichever occurred first; defined as tumor recurrence or death owing to any cause in the patients who received resection), 1-year overall survival rate, DoR, and DCR (including CR, PR, and SD). These endpoints were inputs into the efficacy and safety profiles assayed by the investigators or by the two independent radiologists in the post hoc analysis.