Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. The subject or their legal representative must sign a written informed consent form prior to enrollment. 2. Diagnosis of refractory osteosarcoma confirmed by histopathology. Pathological confirmation is mandatory for localized tumors and isolated pulmonary lesions; it is not required for multiple pulmonary metastases. 3. Disease progression after standard, adequate first-line and second-line chemotherapy regimens for osteosarcoma, or progression within 6 months of stopping such therapy. 4. At least one measurable target lesion according to RECIST version 1.1 criteria. 5. ECOG Performance Status score of 0 or 1, with an expected survival of ≥3 months. 6. Recovery from prior therapies: all side effects (except alopecia) must have resolved to Grade 1 or lower per NCI-CTCAE version 5.0. 7. Adequate organ function as indicated by the following peripheral blood counts and serum biochemistry results 8. Women of childbearing potential must agree to use effective contrace