NCT05926492

A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma

A Prospective, Multicenter, Non-randomized Controlled Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Patients With Osteosarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Surufatinib plus chemotherapy	Surufatinib: (1) for patients aged \> 21 years old and ≤70 years old, surufatinib 200 mg, qd, oral, continuous administration; (2) For patients aged ≥2 years and ≤21 years, starting from the low dose of patient BSA (body surface area), Stevenson's formula developed according to the Chinese population was used: BSA = 0.0061H+0.0128W-0.1529 (H: BSA = 0.0061H+0.0128W-0.1529). Height /cm; W: body weight /kg); Chemotherapy : 1) Doxorubicin 60 mg/m2, or liposome doxorubicin 45mg/ m2, day 17; 2) Cisplatin: 100 mg/m2, day 15; 3) Ifosfamide; 2.5g/m2, day 8-12; The above drugs were used in turn, and 30 days were regarded as a treatment cycle.
DRUG	Chemotherapy	1\) High-dose methotrexate : 8-12 g/m2 (MTX chemotherapy requires blood drug concentration monitoring), day 1 and 8; 2) Doxorubicin 60 mg/m2 or liposomal doxorubicin 45mg/ m2, day 17; 3) Cisplatin: 100 mg/m2, day 15;4) Ifosfamide; 2.5 g/m2, day 8-12. The above drugs were used in turn, and 30 days were regarded as a treatment cycle.

Timeline

• Start date: 2024-01-09
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2023-07-03
• Last updated: 2024-04-17

Locations

1 site across 1 country: China