Actively Recruiting
Brachytherapy (Iodine-125 Seeds) 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
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the effectiveness and safety of radioactive particles in combination with the PARP inhibitor fluzoparib in the treatment of advanced inoperable soft tissue sarcoma.
CONDITIONS
Official 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 (≥10 mm longest diameter or ≥15 mm swollen lymph node) on CT or MRI within 28 days before treatment
- Have a single lesion 5 cm or smaller, with no more than 5 lesions
- Received prior 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 of at least 12 weeks
- Normal function of important organs, including specified blood counts and liver, kidney, and thyroid function levels
- Fertile female patients must use medically recognized contraception during and for 3 months after treatment and have a negative pregnancy test before enrollment
- Male patients with fertile female partners must use effective contraception during treatment and for 3 months after last dose
You will not qualify if you...
- Uncontrolled cardiac conditions such as NYHA class 2 or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Blood clotting abnormalities or bleeding tendencies, or on certain anticoagulant therapies (except prophylactic low-dose aspirin or low-molecular heparin)
- Significant bleeding symptoms or bleeding risk within 3 months prior to enrollment
- Recent arterial or venous thrombotic events within 6 months prior to enrollment
- Known hereditary or acquired bleeding or clotting disorders
- Received chemotherapy or surgery less than 4 weeks before study treatment or not recovered from prior treatment adverse events
- Active infection or fever above 38.5°C within 7 days before dosing
- Other malignancies within the past 3 years except certain skin or cervical cancers
- Established bone metastases treated within 4 weeks prior to enrollment
- Prior external radiotherapy to the lesion
- Pregnant or breastfeeding women, or women of childbearing age not using contraception
- Other serious illnesses or conditions that might affect study outcomes or patient safety, including mental illness requiring treatment or severe lab abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
Dengyao Liu, Ph.D
CONTACT
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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