Tislelizumab Combined With Liposomal Doxorubicin and Ifosfamide as First-line Treatment for Patients With Specified Subtypes of Unresectable or Metastatic Soft Tissue Sarcoma: a Multi-center, Single-arm, Prospective Phase II Clinical Trial
This study will enroll patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, and will combine tislelizumab with the standard chemotherapy of liposomal doxorubicin and ifosfamide to initially explore the efficacy and safety.
• Age 18 to 75 years, regardless of gender;
• Patients with histopathologically confirmed undifferentiated sarcoma (except small round cell undifferentiated sarcoma), synovial sarcoma, angiosarcoma, fibrosarcoma, smooth muscle sarcoma, liposarcoma (except highly differentiated liposarcoma), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath meningiomas, connective tissue-promoting proliferative small round cell tumors, nondifferentiable sarcoma (NOS), and sarcoma after radiation therapy
• Patients with locally advanced disease that is not amenable to surgery/radiation therapy or with recurrent/metastatic disease;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1;
• Expected survival of more than 3 months;
• Within 7 days prior to screening (including day 7), laboratory test data requirements: neutrophil count ≥1.5×10⁹/L, platelet count ≥90×10⁹/L, hemoglobin ≥90g/L (no blood transfusion within 14 days), serum total bilirubin ≤1.5 times the upper limit of normal (ULN); ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastases); serum creatinine ≤1.5× ULN or creatinine clearance rate ≥50ml/min;
• Presence of measurable lesions according to RECIST 1.1 criteria;
• The subject (or their legal representative/guardian) must sign an informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate in this study.