Actively Recruiting
A Phase II Clinical Trial Evaluating Safety and Efficacy of Radioactive Particle and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma
Led by Fujun Zhang · Updated on 2025-05-13
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older
- Pathologically confirmed soft tissue sarcoma with at least one measurable lesion (longest diameter ≥10 mm or swollen lymph node short diameter ≥15 mm) on CT or MRI within 28 days before first treatment
- Single lesion ≤5 cm and no more than 5 lesions
- Received systemic therapy (e.g., doxorubicin plus ifosfamide) with or without surgery as first-line treatment
- Able to swallow pills normally
- ECOG performance status of 0-1
- Expected survival period of at least 12 weeks
- Normal function of important organs with specified blood counts and biochemical levels
- Fertile female patients must use contraception and have negative pregnancy tests; male patients with fertile partners must use contraception during and 3 months after treatment
You will not qualify if you...
- Uncontrolled cardiac symptoms or disease including heart failure class 2 or higher, unstable angina, recent myocardial infarction, significant arrhythmias, or prolonged QTc interval
- Coagulation abnormalities or bleeding tendencies requiring treatment, except low-dose aspirin or low-molecular heparin allowed
- Significant bleeding symptoms or risk within 3 months prior to enrollment
- Recent arterial or venous thrombotic events within 6 months
- Known bleeding or thrombotic disorders
- Prior chemotherapy or surgery within 4 weeks before study dosing or unresolved adverse events from prior treatment
- Active infection or unexplained fever within 7 days before dosing
- Other malignancies within past 3 years except certain skin or cervical cancers
- Bone metastases treated within 4 weeks prior to enrollment
- Prior external radiotherapy to the lesion
- Pregnant or breastfeeding women or women unwilling to use contraception
- Other serious illnesses, substance abuse, or factors affecting safety or study outcome as judged by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year of cumulative dosing
Participants receive radioactive iodine-125 seed implantation followed by oral Fluzoparib 150 mg twice daily after meals for 2 months in a continuous cycle starting 48 hours after implantation. Tumor assessments are performed each cycle. Additional particle implantations (up to 3) may be given for participants with partial remission or stable disease, with drug discontinuation 5 days prior to surgery and resumption 2 days after surgery, continuing until 6 months after the last implantation.
Monthly tumor assessments during treatment cycles and additional visits for particle implantations as needed
Duration - Up to 12 months post-treatment
Participants who discontinue treatment due to toxicity, withdrawal, or disease progression enter survival follow-up to monitor overall survival and safety outcomes.
Periodic follow-up visits as scheduled by the study
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
F
Fujun Zhang, Ph.D,M.D
D
Dengyao Liu, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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