Outcomes and measurements
Tumors, death, SD, Tumor
DISEASE PROGRESSION, ADVERSE EVENT, TUMOR, ADVERSE EVENTS, DISEASE, TUMORS
The primary endpoint was ORR, assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints were PFS, OS, disease control rate (DCR, defined as the best overall response [BOR] of stable disease [SD] or better), duration of response (DOR, defined as the time from first documented complete or partial response [CR or PR] to disease progression or death), and safety and tolerability. Tumor responses were measured using computed tomography or magnetic resonance imaging. Patients underwent imaging evaluations at baseline (treatment initiation), Week 6, Week 12, and then every 9 weeks. After Week 48, imaging evaluations were performed every 12 weeks. Imaging evaluations could be performed within ±7 days of the scheduled visit. CR and PR were confirmed radiologically at least 4 weeks after the first response. Safety was recorded from enrollment until 90 days after the last dose of study treatment. Treatment‐emergent adverse events (TEAEs), treatment‐related adverse events (TRAEs), and laboratory biochemical data parameters were summarized using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.01.