Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-11 @ 9:02 PM
Study NCT ID:
NCT05894018
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma
Sponsor:
Fujun Zhang
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial Evaluating the Safety and Efficacy of Radioactive Particle and Fluzoparib Combination Therapy in the Treatment of Advanced Unresectable Soft Tissue Sarcoma
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAFAS-001
Brief Summary:
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.
Detailed Description:
Fluzoparib 150 mg Bid was given orally after meals for 2 months (60 days) in a continuous cycle 48 h after radioactive particle implantation. The maximum cumulative dosing period is 1 year. Tumor assessment was performed in each cycle. The first cycle is evaluated every month. Patients in partial remission (PR) or patients with stable disease (SD) will be supplemented with additional particle implantations (≤3) according to the dose prescribed by the physician, noting the need to discontinue the drug for at least 5 days prior to surgery and to continue oral Fluzoparib for 2 days after surgery until 6 months after the last particle implantation. Patients with intolerable toxicity or patient requested discontinuation or disease progression (PD) were withdrawn from the trial and entered into survival follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: