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 Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
117
Anlotinib QD po.
Placebo QD po.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing chest hospital,capital medical university
Beijing, Beijing Municipality, China
Xinqiao Hospital, Third Military Medical University
enhanced CT/MRI scan
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1.
Time frame: each 42 days up to disease progression
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0
Time frame: each 21 days up to intolerance the toxicity(or PD)
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Chongqing, Chongqing Municipality, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Jilin province tumor hospital
Changchun, Jilin, China
Shandong Province Tumor Hospital
Jinan, Shandong, China
Chest hospital affiliated to Shanghai jiaotong university
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
...and 3 more locations