Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.
It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting103 patients who were progressed after first line systemic therapy and refused/can't tolerate chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
Shaanxi Provincial Cancer Hospital
Xian, Shanxi, China
RECRUITINGDuration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
Progress free survival (PFS)
Time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Duration of Overall Survival (OS) as Assessed by the Investigator Using RECIST v1.1
Overall Survival (OS)
Time frame: Baseline until death from any cause (up to approximately 24 months)
Disease Control Rate (DCR)as Assessed by the Investigator Using RECIST v1.1
Disease Control Rate (DCR)
Time frame: First occurrence of PR or CR until PD or death, whichever occurs first (up to 24 months)
Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1
Objective Response Rate (ORR)
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to 24 months)
Percentage of Participants with Adverse Events
Percentage of Participants with Adverse Events
Time frame: Baseline until up to 21 days after end of treatment
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