Phase II Study of Radioactive Iodine-125 Seed Implantation Combined with Fluzoparib for Treating Advanced Unresectable Soft Tissue Sarcoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining radioactive particles with the drug fluzoparib to treat advanced, inoperable soft tissue sarcoma. This phase II clinical trial focuses on patients with measurable tumors that cannot be surgically removed, aiming to understand how well this combination works in controlling the disease. Participants receive implantation of radioactive iodine-125 seeds followed by oral doses of fluzoparib at 150 mg twice daily after meals, starting 48 hours after the implantation. Fluzoparib is given continuously for 2 months per cycle, with tumor assessments monthly during the first cycle. Depending on tumor response, additional particle implantations up to three may be given, with medication pauses before surgeries and continuation after surgery until 6 months after the last implantation. The maximum treatment duration with fluzoparib is one year. Throughout the study, patients undergo regular tumor evaluations using CT or MRI scans and monitoring for side effects. Key outcomes include the objective response rate after 12 months, progression-free survival at multiple time points, overall survival rates, and safety events. Patients who experience intolerable side effects, disease progression, or choose to stop treatment enter a survival follow-up phase. The total participation may extend until study completion in December 2028.

Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma