Endpoints and Assessment
death, SD, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, DISEASE, SECONDARY, CANCER
The primary endpoint was progression-free survival (PFS), the time from randomization to disease progression or death from any cause, whichever occurred first. The secondary endpoints included the objective response rate (ORR, defined as the proportion of patients with the best overall response of the complete response [CR] and partial response [PR]) as per RECIST version 1.1, disease control rate (DCR, defined as the proportion of patients with CR, PR, and stable disease [SD]), overall survival (OS, defined as the time from randomization to death from any cause), and safety. Radiologic assessment was performed by 2 independent investigators every 8 weeks during the treatment period, until disease progression, death, or consent withdrawal. The investigator assessed AEs were assessed and classified according to severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.