“The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC. The primary endpoint is progression free survival (“PFS”) per RECIST 1.1 as assessed by blinded independent central review (BICR). The secondary endpoints include objective response rate (“ORR”), disease control rate (“DCR”), duration of response (“DoR”), time to response (TTR), overall survival (“OS”), safety, and quality of life. A total of 234 patients have been enrolled in the study. The leading principal investigators are Dr Dingwei Ye of Fudan University Shanghai Cancer Center and Dr Zhisong He of Peking University First Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231.”
