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RECRUITING
NCT05926492
PHASE2

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-01-09

Completion Date

2026-07

Last Updated

2024-04-17

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China