Tislelizumab Combined With Liposomal Doxorubicin and Ifosfamide as First Treatment for Patients With Unresectable or Metastatic Soft Tissue Sarcoma Subtypes A Multi-center Phase II Trial

What this Trial Is About

Researchers are evaluating a treatment for patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, a rare cancer that arises from soft tissues and can spread to various body parts. This study looks at combining tislelizumab, an immune checkpoint inhibitor, with the standard chemotherapy drugs liposomal doxorubicin and ifosfamide to explore their combined effectiveness and safety. Soft tissue sarcomas are often difficult to treat once they spread, with limited survival times, making new treatment approaches important. Participants will receive tislelizumab at 200 mg via intravenous infusion on day 1, along with liposomal doxorubicin at 30 mgm2 on day 1 and ifosfamide at 3 gm2 per day on days 1 to 3. These treatments are given every three weeks as a first-line therapy. The study is a single-arm, prospective trial focusing on this combination over multiple treatment cycles. During the study, patients will be monitored for response to treatment, including tumor shrinkage and progression, using established criteria over a period of up to 36 months. Researchers will assess overall response rate as the primary outcome, along with progression-free survival, overall survival, and quality of life questionnaires. Safety and side effects will be closely followed, and participants will have regular laboratory tests and clinical evaluations throughout their involvement, which may last several years.

IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)