Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA:2011L00661) which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Anlotinib p.o. qd
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Gansu Province Tumor Hospital
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, China
Harbin medical university affiliated tumor hospital
Haerbin, Heilongjiang, China
The 81st Hospital of Chinese PLA
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
China General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
...and 5 more locations
Progress Free Survival (PFS)
The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"
Time frame: each 42 days up to PD or death (up to 36 months)
Objective Response Rate
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
Time frame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Disease Control Rate (DCR)
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).
Time frame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
Overall Survival (OS)
OS was defined as time from date of randomization to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.
Time frame: From randomization until death (up to 36 months)
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