drugset / Trial / NCT07142863

Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients

NCT07142863

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-25
Primary completion
2026-08-31
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 2.5 mg/kg Subcutaneous
Subject Envafolimab Monoclonal antibody 200 mg Subcutaneous
Background Cisplatin Other / unclassified 120 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Background Ifosfamide Small molecule 12 g Intravenous
Background Ifosfamide Small molecule 15 g Intravenous
Background Methotrexate Small molecule 8 g Intravenous
Background Methotrexate Small molecule 12 g Intravenous

Indications