The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle).Sintilimab was administered intravenously (200mg once every 3weeks).
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
progression-free survival (PFS)
Time from treatment until disease progression or death
Time frame: up to 2 years
objective response rate (ORR)
objective response rate (ORR) by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR)
Time frame: up to 2 years
disease control rate (DCR)
disease control rate (DCR)by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) and Stable Disease(SD).
Time frame: up to 2 years
overall survival (OS)
Time from treatment until death from any cause
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 2 years
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