NCT07142863

Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients

Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.

Conditions

• Osteosarcoma
• Neoadjuvant Therapy
• Neoadjuvant Chemotherapy
• PD-L1 Antibody
• Envafolimab

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-08-31
• Completion: 2026-09-30
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: China