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Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma
Sponsor: Peking University People's Hospital
Summary
In advanced osteosarcoma where traditional chemotherapy has failed, the multi-targeted tyrosine kinase inhibitor apatinib has become a mainstream systemic treatment option in China. However, for patients with a high tumor burden or extra-pulmonary lesions, these drugs are prone to secondary resistance, necessitating combination with chemotherapy for more effective comprehensive control. Liposomal irinotecan, a newly approved topoisomerase inhibitor, exhibits lower toxicity compared to traditional irinotecan and is one of the second-line chemotherapy agents for osteosarcoma, making it a suitable candidate for combination therapy with apatinib. The primary objective of this study is to determine the optimal regimen of apatinib combined with liposomal irinotecan injection, while the secondary objective is to evaluate the safety and efficacy of this combination in patients with refractory osteosarcoma who have progressed after second-line chemotherapy.
Official title: Safety and Efficacy of Apatinib Combined With Irinotecan Liposome Injection in the Treatment of Recurrent or Metastatic Osteosarcoma: A Single-Arm, Open-Label, Prospective Multicenter Clinical Study
Key Details
Gender
All
Age Range
12 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2026-03-05
Completion Date
2028-01-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Liposomal Irinotecan
Intravenous liposomal irinotecan administered on Day 1, 8, and 15 of each 3-week cycle.
Apatinib in arm1
Oral VEGFR-2 tyrosine kinase inhibitor administered in combination with liposomal irinotecan.
Locations (1)
Peking University People's Hospital
Beijing, China