This study is a multicenter, open-label, randomized controlled trial that enrolled 116 patients with advanced or metastatic renal cell carcinoma who had failed first-line treatment with PD-1/PD-L1 monotherapy or VEGFR TKI combined with PD-1/PD-L1 therapy. Patients were randomly assigned in a 1:1 ratio to receive either the experimental group treatment with vorolanib tablets combined with everolimus or the control group treatment with sunitinib as second-line therapy until disease progression. The study aimed to evaluate the efficacy and safety of vorolanib tablets combined with everolimus as second-line therapy for renal cell carcinoma patients.
Pathologically confirmed renal clear cell carcinoma (histological or cytological);
Subjects who have failed prior treatment with a single anti-PD-1/PD-L1 agent or a combination of anti-PD-1/PD-L1 and anti-VEGFR TKI;
Age 18 to 80 years;
Estimated survival exceeding 12 weeks;
Patients who have received one or more prior systemic anticancer treatment regimens for clear cell renal cell carcinoma;
Patients who have not previously received immunosuppressive therapy for advanced renal cell carcinoma;
Subjects currently undergoing anticancer therapy (excluding local radiotherapy for bone metastases);
Subjects with known hypersensitivity to similar drugs;