Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Inclusion criteria

• ✓. The subject or their legal representative must sign a written informed consent form prior to enrollment.
• ✓. 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.
• ✓. Disease progression after standard, adequate first-line and second-line chemotherapy regimens for osteosarcoma, or progression within 6 months of stopping such therapy.
• ✓. At least one measurable target lesion according to RECIST version 1.1 criteria.
• ✓. ECOG Performance Status score of 0 or 1, with an expected survival of ≥3 months.
• ✓. Recovery from prior therapies: all side effects (except alopecia) must have resolved to Grade 1 or lower per NCI-CTCAE version 5.0.
• ✓. Adequate organ function as indicated by the following peripheral blood counts and serum biochemistry results
• ✓. Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion; they must have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must not be breastfeeding. Male participants must agree to use effective contraception or have undergone surgical sterilization during the study and for 6 months after its completion.