Sarcoma,Soft TissuePhase 2RAFAS-001NCT05894018
Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma
A Phase 2 study testing Fluzoparib and Radioactive particle implantation in people with Sarcoma,Soft Tissue and Brachytherapy, run by Fujun Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma,Soft Tissue, Brachytherapy, Poly(ADP-ribose) Polymerase Inhibitors
- What is being tested?
- Fluzoparib and Radioactive particle implantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2023to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Received systemic therapy (such as standard treatment: doxorubicin plus ifosfamide) ± surgical resection as the first-line treatment;
- Able to swallow pills normally;
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- ECOG performance status of 0-1;
- Expected survival period ≥12 weeks;
- Normal function of important organs, including:
- Absolute neutrophil count ≥1.5×109/L;Platelets ≥80×109/L;Hemoglobin ≥90 g/L;Serum albumin ≥28 g/L;Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously, and if FT3 and FT4 levels are normal, patients can be included);Bilirubin ≤1.5×ULN (within 7 days before the first treatment);ALT and AST ≤3×ULN (within 7 days before the first treatment);Alkaline phosphatase (AKP) ≤2.5×ULN;Serum creatinine ≤1.5×ULN; Non-surgically sterilized or fertile female patients need to use a medically recognized contraceptive measure (such as an intrauterine device, birth control pills, or condoms) during the study treatment period and within 3 months after the end of the study treatment. Fertile female patients who are not surgically sterilized must have a negative serum or urine HCG test within 72 hours before study enrollment and must not be breastfeeding. Male patients with fertile female partners should also use effective contraception during the trial period and for 3 months after the last dose of the study treatment.
Who cannot join
- 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;
- Known hereditary or acquired bleeding and thrombotic predisposition (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- Patients who have received prior chemotherapy, surgery, less than 4 weeks after completion of treatment (last dose) and prior to study dosing; or patients who have not recovered from adverse events (other than alopecia) caused by prior treatment to ≤ CTCAE grade 1;
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- Patients with active infection, unexplained fever ≥38.5°C within 7 days prior to dosing, or white blood cell count >15×109/L at baseline;
- Patients with other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within the previous 3 years or concurrently;
- Patients with established bone metastases who have received, within 4 weeks prior to enrollment in the study;
- Prior external radiotherapy to the lesion;
- Pregnant or breastfeeding women, or women of childbearing age who do not wish to use contraception;
- Patients who, in the judgment of the investigator, have other factors that may affect the outcome of the study or force the termination of the study, such as alcoholism, substance abuse, other serious illnesses (including mental illness) requiring comorbid treatment, severe abnormal laboratory tests, accompanied by family or social factors that would affect the safety of the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Funjun Zhang, Ph.D,M.D, +8613826222266, zhangfj@sysucc.org.cn
About this study
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
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.
Read the 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.
- Being tested
- Fluzoparib, Radioactive particle implantation
- Keywords
- Fluzoparib, Radioactive particles, Iodine-125 seed
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
150mg, orally, bid
Radioactive particle implantationProcedure or surgery
Radioactive iodine-125 seeds implantation
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib+radioactive particle implantation | Experimental | Fluzoparib 150 mg bid was given orally after meals for 2 months (60 days) in a continuous cycle 48h after radioactive particle implantation. Receives: Drug: Fluzoparib; Procedure: Radioactive particle implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Overall survival rate
Defined as the proportion of patients who are still alive at 18 months from the initiation
Measured: 18 months
AE, SAE
The incidence of adverse events (AE), serious adverse events (SAE)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start29 Jun 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma,Soft TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fujun Zhang, Sun Yat-sen University
- Investigators
- Fujun Zhang, Ph.D,M.D, Study director, Sun Yat-sen UniversityXing Zhang, Ph.D,M.D, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894018
- Sponsor's protocol ID
- SL-B2023-135-02
- Acronym
- RAFAS-001
- Status last verified
- May 2025
- First submitted
- 26 May 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05894018
- Acronym / sponsor ID
- RAFAS-001 / SL-B2023-135-02
- Keywords
- Fluzoparib, Radioactive particles, Iodine-125 seed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fujun ZhangUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib+radioactive particle implantation | Experimental | Drug: Fluzoparib, Procedure: Radioactive particle implantationFluzoparib 150 mg bid was given orally after meals for 2 months (60 days) in a continuous cycle 48h after radioactive particle implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- Received systemic therapy (such as standard treatment: doxorubicin plus ifosfamide) ± surgical resection as the first-line treatment;
Key exclusion criteria (12 listed)
- 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;
- Known hereditary or acquired bleeding and thrombotic predisposition (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzoparib150mg, orally, bid | Drug | Fluzoparib+radioactive particle implantation |
| Radioactive particle implantationRadioactive iodine-125 seeds implantation | Procedure or surgery | Fluzoparib+radioactive particle implantation |
Primary outcome
Objective Response Rate (ORR)
Time frame: 12 months
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.
9 secondary outcomes
Progression-free survival rate(PFS)
Time frame: 6 months
Progression-free survival rate(PFS)
Time frame: 12 months
Progression-free survival rate(PFS)
Time frame: 18 months
Disease control rate(DCR)
Time frame: 12 months
Overall survival(OS)
Time frame: 12 months
Overall survival rate
Time frame: 6 months
Overall survival rate
Time frame: 12 months
Overall survival rate
Time frame: 18 months
AE, SAE
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fujun Zhang, Ph.D,M.D study director
Sun Yat-sen University
Xing Zhang, Ph.D,M.D study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluzoparib and Radioactive particle implantation in people with Sarcoma,Soft Tissue and Brachytherapy, run by Fujun Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fujun Zhang, Ph.D,M.D (+8613826222266, zhangfj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.