Anlotinib Hydrochloride Combined With Epirubicin & Ifosfamide for Soft

Status Recruiting

Clinical Trial 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 plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03815474
Study type	Interventional
Source	Liaoning Tumor Hospital & Institute
Contact	Li Shenglong, master
Phone	18900918348
Email	lishenglong@cancerhosp-ln-cmu.com
Status	Recruiting
Phase	Phase 2
Start date	May 20, 2019
Completion date	December 31, 2020

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See also
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Active, not recruiting	`NCT06114173` - Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma	Early Phase 1
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients — ALTER-S005

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms