Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and tumor cell proliferation related kinase c-Kit kinase. Anlotinib is an efficient second line therapeutic agent in treatment for metastatic soft tissue sarcoma which has been approved in clinical trials (ALTER-0203). Therefore, this study evaluates the safety and efficacy of anlotinib as maintenance treatment of disease control in advanced soft tissue sarcoma.
48 cases are preliminarily expected to be included. This study evaluating the safety and efficacy of anlotinib as a maintenance treatment after first-line anthracycline-based chemotherapy in advanced soft tissue sarcoma. All those participants need to sign informed consent forms for data collection and be used for research purpose before inclusion. Participants remained PR/SD after ≥4 cycles of anthracyclines could be enrolled. 48 subjects with advanced soft tissue sarcoma will receive anlotinib at a dose of 12 mg once daily (day1-14 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
48 subjects with advanced soft tissue sarcoma will receive anlotinib at a dose of 12 mg once daily (day1-14 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) or unacceptable toxicity.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgress free survival for anlotinib maintenance treatment
Progress free survival defined as the time from first dose of anlotinib treatment until the first date of either objective disease progression or death due to any cause. If the subject did not experience disease progression or death, PFS is defined as the period from the treatment start to the date of the last confirmed progression-free.
Time frame: until Progressive Disease(PD) or death (up to 24 months)
Overall Survival
Overall survival is defined as the time until death due to any cause.
Time frame: From randomization until death (up to 24 months)
Objective Response Rate
Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Safety profile
Adverse events were recorded throughout the treatment period and 21 days after the last dose and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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