Phase II Study of MASCT-I with Doxorubicin and Ifosfamide as First Treatment for Advanced Soft Tissue Sarcoma

What this Trial Is About

Researchers are evaluating the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide as a first treatment option for patients with advanced soft tissue sarcoma who have metastatic or recurrent unresectable disease. This randomized, open-label Phase II study focuses on several types of soft tissue sarcoma, including leiomyosarcoma, liposarcoma, synovial sarcoma, and others, aiming to understand how well this combination works and its safety profile. The study includes two treatment groups one receiving MASCT-I together with Doxorubicin and Ifosfamide, and the other receiving only Doxorubicin and Ifosfamide. MASCT-I involves injections of dendritic cells given under the skin and effector T cells given intravenously. Doxorubicin and Ifosfamide are administered according to the treatment protocol. Participants receive these treatments as their first-line therapy for advanced disease. Participants will be closely monitored through various assessments over three years, including measuring progression-free survival as the main outcome. Other outcomes include overall survival, response rates, disease control, duration of response, and safety through adverse event monitoring and laboratory tests. The study involves regular evaluations to track treatment effects and side effects, with participant involvement lasting up to three years.

MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma