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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05926492
Phase
PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Surufatinib plus chemotherapy — DRUG
    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.
  • Chemotherapy — DRUG
    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.

Study Details

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

Key Dates

First listed
Jul 3, 2023
Start date
Jan 9, 2024
Status verified
Jun 2023
Primary completion
Jul 31, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surufatinib plus chemotherapy
    Patients were to receive surufatinib plus chemotherapy every 30 days as neoadjuvant treatment. After receiving 2 cycles of treatment, patients will be evaluated for tumor necrosis rate.
  • Active Comparator: Chemotherapy
    Patients were to receive chemotherapy every 30 days as neoadjuvant treatment. After receiving 2 cycles of treatment, patients will be evaluated for tumor necrosis rate.

Primary Outcome Measure

Tumor cell necrosis rate (TCNR) [ Time Frame: 12 months ]

Central Contacts

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