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 well differentiated liposarcoma), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath meningiomas, desmoplastic small round cell tumor, not other specified (NOS), SMARCA4-deficient sarcoma, malignant phyllodes tumor of the breast, intimal sarcoma.
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;
Previous treatment for advanced soft tissue sarcoma, except for those who relapsed more than six months after adjuvant therapy with a cumulative dose of doxorubicin ≤300mg/m2;
Received any experimental or anti - tumor drugs within 4 weeks prior to enrollment;
Previously received any anti - PD - 1, anti - PD - L1, anti - PD - L2, anti - CD137, or anti - CTLA - 4 antibody treatment, or any other antibodies or drugs specifically targeting T - cell co - stimulation or checkpoint pathways;
History of other tumors within the past five years, except for cured cervical cancer or skin basal cell carcinoma; for patients with post - radiation sarcoma, another primary tumor must have no recurrence or metastasis;
Fudan University
Lead sponsor