Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

August 25, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

September 30, 2026

Conditions
OsteosarcomaNeoadjuvant TherapyNeoadjuvant ChemotherapyPD-L1 AntibodyEnvafolimab
Interventions
DRUG

Envafolimab and neoadjuvant chemotherapy

"\* PD-L1 inhibitor envafolimab Paediatric (\<18 years): 2.5 mg/kg (maximum 200 mg) by subcutaneous injection on Day 1 of every week (q1w).~Adult (≥18 years): 200 mg flat dose by subcutaneous injection on Day 1 of every week (q1w).~* Neoadjuvant chemotherapy--MAP regimen (paediatric patients) Doxorubicin 75 mg/m² intravenously on Days 1-2, administered in weeks 1 and 6 of each 6-week cycle.~Cisplatin 120 mg/m² intravenously on Days 1-3, administered in weeks 1 and 6 of each 6-week cycle.~Methotrexate 8-12 g/m² intravenously on Day 1 of weeks 3 and 4 of each 6-week cycle.~* Neoadjuvant chemotherapy--DIA regimen (adult patients) Doxorubicin 75 mg/m² intravenously on Days 1-2, administered in weeks 1 and 6 of each 6-week cycle.~Cisplatin 120 mg/m² intravenously on Days 1-3, administered in weeks 1 and 6 of each 6-week cycle.~Ifosfamide 12-15 g/m² total dose intravenously on Days 1-5 of week 3 of each 6-week cycle."

Trial Locations (1)

Unknown

Shanghai First People's Hospital, 100 Haining Road, Hongkou District, Shanghai

All Listed Sponsors
lead

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER