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.
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 Patients with intolerable toxicity or patient requested discontinuation or disease progression (PD) were withdrawn from the trial and entered into survival follow-up.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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
150mg, orally, bid
Radioactive iodine-125 seeds implantation
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of The proportion of patients achieving complete response (CR, tumor disappearance) or partial response (PR, tumor shrinkage) as evaluated by researchers based on the RECIST 1.1 criteria after receiving treatment.
Time frame: 12 months
Progression-free survival rate(PFS)
Based on RECIST 1.1 criteria, all patients were evaluated from the first day of iodine-125 seeds brachytherapy treatment until objective tumor progression or death from any cause. The percentage of subjects with progression-free survival at 6 months after treatment was calculated using the Kaplan-Meier method.
Time frame: 6 months
Progression-free survival rate(PFS)
Based on RECIST 1.1 criteria, all patients were evaluated from the first day of iodine-125 seeds brachytherapy treatment until objective tumor progression or death from any cause. The percentage of subjects with progression-free survival at 12 months after treatment was calculated using the Kaplan-Meier method.
Time frame: 12 months
Progression-free survival rate(PFS)
Based on RECIST 1.1 criteria, all patients were evaluated from the first day of iodine-125 seeds brachytherapy treatment until objective tumor progression or death from any cause. The percentage of subjects with progression-free survival at 18 months after treatment was calculated using the Kaplan-Meier method.
Time frame: 18 months
Disease control rate(DCR)
Defined as the proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) for at least 4 weeks after treatment.
Time frame: 12 months
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Overall survival(OS)
Defined as the time interval from the date of enrollment to death from any cause, with censoring at the last known alive date if no death has occurred.
Time frame: 12 months
Overall survival rate
Defined as the proportion of patients who are still alive at 6 months from the initiation of treatment during follow-up.
Time frame: 6 months
Overall survival rate
Defined as the proportion of patients who are still alive at 12 months from the initiation of treatment during follow-up.
Time frame: 12 months
Overall survival rate
Defined as the proportion of patients who are still alive at 18 months from the initiation
Time frame: 18 months
AE, SAE
The incidence of adverse events (AE), serious adverse events (SAE)
Time frame: 12 months