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 plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .
This study is planned to be carried out in Liaoning, Jilin and Harbin provinces regional multi-center. 47 cases are preliminarily expected to be included. The study started in January 2019 and ended in December 2019. It is expected that the trial will end in December 2020. This study is a phase 2 study evaluating the safety and efficacy anlotinib and plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma . All those participants need to sign informed consent forms for data collection and use for research purpose before inclusion .Those participants who were not treated with anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months should be enrolled. 47 subjects with metastatic or advanced soft tissue sarcoma will receive epirubicin at 30mg/m2/day(day1-2 IV), ifosfamide at 1.8g/m2/day (day1-5 IV) anlotinib at a dose of 12 mg once daily (day8-21 PO). After 6 treatment cycles,those participants will receive anlotinib at a dose of 12 mg once daily (day8-21 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) ot unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
RECRUITINGProgress free survival
Progress free survival (PFS) defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Time frame: Until Progressive Disease(PD) or death(up to 24 months)
Overall Survival
Overall Survival (OS) 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 (ORR) 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(Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety)
Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety.
Time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
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