Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma

Exclusion Criteria

• •1. Prior treatment with apatinib.
• •2. Prior use of irinotecan or other analogues of topoisomerase inhibitors.
• •3. Known allergic reactions, hypersensitivity, or intolerance to apatinib, liposomal irinotecan, or any of their excipients.
• •4. Within 3 weeks after the last dose of any prior therapy, including systemic cytotoxic drug therapy, targeted therapy, radiotherapy, immunotherapy, or any other investigational therapy.
• •5. Diagnosis of other malignancies within the past 3 years, except for adequately treated cutaneous basal cell carcinoma, carcinoma in situ of the cervix, or breast cancer that has undergone radical resection and remained disease-free for \>3 years.
• •6. Patients with known brain metastasis, spinal cord compression, carcinomatous meningitis, or those with imaging evidence of leptomeningeal disease or unstable brain lesions detected by CT or MRI during screening.
• •7. Patients with symptomatic serous cavity effusions (e.g., pleural effusion, ascites, or pericardial effusion) requiring surgical intervention.
• •8. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite optimal medical therapy).
• •9. Other poorly controlled diseases.
• •10. Participation in clinical trials of other antitumor drugs within the 4 weeks prior to enrollment.
• •11. Treatment with strong CYP3A4 inhibitors within 7 days prior to study participation, or treatment with strong CYP3A4 inducers within 12 days prior to study participation.
• •12. Patients currently receiving concurrent antitumor therapy.
• •13. Patients with target lesions having previously received radiotherapy, but without subsequent progression.
• •14. Patients who have received any vaccination during the treatment period, or have received an adenovirus-based vaccine within 4 weeks.
• •15. Lactating women.
• •16. Any condition that, in the investigator's judgment, may compromise the subject's well-being or ability to comply with or fulfill the study requirements.