NCT03792542

Anlotinib Hydrochloride For Advanced Soft Tissue Sarcoma Patients Who Do Not Receive Chemotherapy

Anlotinib Hydrochloride for Advanced Soft Tissue Sarcoma Patients Who do Not Receive Chemotherapy:a One-arm, Multi-center, Prospective Clinical Trial(ALTER-S003)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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). There is a sort of patients who are not candidate for standard first line chemotherapy that is doxorubicin based. The patients either refused or too old and and debilitated to receive the cytotoxic chemotherapy.

Detailed description

This study is planned to be carried out in Zhejiang and Jiangsu province regional multi-center. 44 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. In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib Hydrochloride ( 12mg, quaque die（QD）, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from adverse events(AEs), they can get declined dosage.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-01-03
• Last updated: 2019-01-03

Locations

1 site across 1 country: China