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Clinical Trial Summary

This phase II study aims to explore the tumor necrosis rate in osteosarcoma patients treated with a neoadjuvant regimen of surufatinib combined with chemotherapy.


Clinical Trial Description

Surufatinib is a potent inhibitor of colony-stimulating factor 1 receptor(CSF-1R), which shows a promising tumor inhibition effect on sarcoma. This is a prospective, multicenter, controlled phase II study to explore the efficacy and safety of surufatinib combined with chemotherapy in neoadjuvant treatment of osteosarcoma. In this study, 160 patients were enrolled into the following treatment groups with a 1:1 ratio: (1) Surufatinib + chemotherapy group (N=80) (2) control group: chemotherapy group (N=80); A 30-day treatment cycle was performed, the efficacy was evaluated after 2 cycles of neoadjuvant therapy. The primary endpoints were tumor necrosis rate, and secondary endpoints were 1-year progression-free survival (PFS) and drug safety. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05926492
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Binghao Li, PhD
Phone +86-17764527695
Email libinghaohz@163.com
Status Recruiting
Phase Phase 2
Start date January 9, 2024
Completion date July 2026

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