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

NCT05926492 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-04-17

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2025-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926492 on ClinicalTrials.gov