Endpoints and assessments
tumor, SD, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, ADVERSE EVENT, EVENT, DISEASE, CANCER
The primary endpoints were safety and ORR assessed by independent radiological review committee (IRRC) based on RECIST version 1.1. Safety consisted of monitoring and documenting all adverse events (AEs) that were evaluated based on the incidence and severity. All AEs were described according to the Medical Dictionary for Regulatory Activities version 23.1 and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. For any multiple occurrences of the same event, the one with the worst grade was recorded. Adverse event of special interest included infusion-related reactions and immune-related AEs. ORR was defined as the percentage of subjects whose best overall responses were complete response (CR) and partial response (PR).Secondary endpoints included ORR (assessed by the investigator according to RECIST version 1.1), PFS (assessed by investigator and IRRC according to RECIST version 1.1), 6-month PFS rate, OS, 6-month OS rate, duration of response (DOR), and disease control rate (DCR) defined as proportion of patients with CR, PR, or stable disease (SD). Both CR or PR must be confirmed by tumor evaluation after 28 days and SD lasting ≥42 days.