Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title: A Single-arm, Open, Multicenter Study of Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma

Status Recruiting

Clinical Trial Summary

Apatinib mesylate is a multitarget receptor tyrosine kinase inhibitor. This trial is to evaluate the efficacy and safety of apatinib mesylate combined with doxorubicin and ifosfamide in the treatment of advanced soft tissue sarcoma.

Clinical Trial Description

Apatinib mesylate has demonstrated good efficacy and acceptable safety in patients with metastatic or recurrent soft tissue sarcoma (STS). A retrospective study has evaluated the efficacy of apatinib in the treatment of advanced soft tissue sarcoma. A total of 31 patients with soft tissue sarcoma were enrolled in this study, including 4 patients receiving apatinib first-line treatment, 8 patients receiving second-line treatment, and 19 patients receiving third-line or post-third-line treatment. The results showed that ORR 33.3%, DCR 75%, and mTTP 4.6 months (1.8-11.6 months). In another multicentric retrospective study of apatinib for osteosarcoma and soft tissue sarcoma, a total of 56 patients were enrolled and 44 were treated with apatinib monotherapy. The overall results showed that ORR was 62.5%, mPFS was 6.6 months, and mOS was 9.9 months. In a phase II multi-center single-arm study results published by Yang Jilong Yang et al at the 2018 AACR conference, ORR and DCR at 3 months also reached 13.95% and 81.39%, respectively. The end point assessment ORR was further increased to 15.25% at the end of the study, because some patients achieved partial remission after a long period of treatment, and the final DCR reached 57.63%. Apatinib had a significant effect in the treatment of stage IV osteosarcoma with failed chemotherapy. Jing Chen et al published a study researching the effectiveness and security in advanced sarcoma patients after apatinib treatment , the results show that 24.3% of subjects to achieve objective response, including 1 case of adenoid vesicular soft tissue sarcoma patients achieved CR, seven adenoid vesicular soft tissue sarcoma patients achieved the objective response, indicates that apatinib is effective and well tolerated in some specific sarcoma subtype.

In this study ,Apatinib mesylate combined with doxorubicin and ifosfamide regimens were evaluated in the treatment of advanced or inoperable STS to determine the potential to achieve better outcomes. ;

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

• NCT number: NCT04012827
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Xing Zhang
• Phone: 02087343383
• Email: zhangxing@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: August 20, 2019
• Completion date: December 31, 2023