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Spots Global Cancer Trial Database for Anlotinib Maintenance Treatment for Advanced Soft Tissue Sarcoma

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Trial Identification

Brief Title: Anlotinib Maintenance Treatment for Advanced Soft Tissue Sarcoma

Official Title: A Single-arm, Multicentre, Phase II Clinical Trial of Anlotinib Maintenance Treatment After First-line Anthracycline-based Chemotherapy in Advanced Soft Tissue Sarcoma (ALTER-S006)

Study ID: NCT03890068

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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