Study objectives and assessment
death, SD, Tumor
DISEASE, DISEASE PROGRESSION, SECONDARY, TUMOR
The primary objective of the study was to evaluate progression-free survival (PFS) in the intent-to-treat (ITT) population. PFS was defined as the time from the first dose of PLD to disease progression per the RECIST 1.1 criteria, death from any cause without progression, or the last follow-up visit without progression. The secondary objectives included overall survival (OS), objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), and safety. OS was defined as the time from the first dose of PLD to death from any cause, and it was censored at the date of the last follow-up. ORR was defined as the percentage of patients with the best overall response of complete response (CR) or partial response (PR) per the RECIST 1.1 criteria (without confirmation), DCR was defined as the percentage of patients with CR, PR, or stable disease (SD), and CBR was defined as the percentage of CR, PR, or SD for at least 24 weeks. Tumor responses were accessed by computer tomography/magnetic resonance imaging every two cycles (every 8 weeks) during treatment and every 3 months after discontinuation until disease progression according to RECIST version 1.1[