NCT03815474

Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients

Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Locally Recurrent or Metastatic Soft Tissue Sarcoma Patients: a One-arm, Multi-center, Prospective Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Liaoning Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 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).Therefore , this study evaluates the safety and efficacy of anlotinib plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .

Detailed 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.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	anlotinib	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

Timeline

• Start date: 2019-05-20
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2019-01-24
• Last updated: 2019-07-09

Locations

1 site across 1 country: China