IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)
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.
| Condition(s) | Soft Tissue Sarcomas, Angiosarcoma, Fibrosarcoma, Leiomyosarcoma, Pleomorphic Liposarcoma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Desmoplastic Small Round Cell Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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; * Expected survival of more than 3 months; * Withi |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-02-25 |
| NCT ID | NCT06849986 |
| Official listing | https://clinicaltrials.gov/study/NCT06849986 |