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

ConditionsSarcoma,Soft TissueBrachytherapyPoly(ADP-ribose) Polymerase Inhibitors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujun Zhang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily agree to participate in this study and sign an informed consent form;

Age ≥18 (calculated on the day of signing the informed consent), regardless of gender;

Pathologically confirmed soft tissue sarcoma, with at least one measurable lesion according to RECIST 1.1 criteria on CT or MRI scan, within 28 days before the first study treatment (the longest diameter of the lesion ≥10 mm or the short diameter of swollen lymph node ≥15 mm);

A single lesion ≤5cm and no more than 5 lesions;

Disqualifiers

Clinical cardiac symptoms or disease that were not well controlled, such as: NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, QTc>450ms (men); QTc>470ms (women);

Coagulation abnormal function (INR>2.0, PT>16s), bleeding tendency or on thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin, low-molecular heparin allowed;

Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as daily cough/hemoptysis of 2.5 ml or more, gastrointestinal bleeding, esophagogastric fundic varices with bleeding risk ;

Arterial/venous thrombotic events such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, and cerebrovascular disease) that occurred within 6 months prior to enrollment. ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;

Trial design

Design model

Single group

Treatments tested in this trial

  • Fluzoparib

    Drug

    150mg, orally, bid

  • Radioactive particle implantation

    Procedure/Surgery

    Radioactive iodine-125 seeds implantation

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Fluzoparib+radioactive particle implantationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujun Zhang

Lead sponsor

Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov
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