Overview

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

Inclusion Criteria:

1. Voluntarily agree to participate in this study and sign an informed consent form;
2. Age ≥18 (calculated on the day of signing the informed consent), regardless of gender;
3. 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);
4. A single lesion ≤5cm and no more than 5 lesions;
5. Received systemic therapy (such as standard treatment: doxorubicin plus ifosfamide) ± surgical resection as the first-line treatment;
6. Able to swallow pills normally;
7. ECOG performance status of 0-1;
8. Expected survival period ≥12 weeks;
9. 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.
        Exclusion Criteria:
          1. 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);
          2. 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;
          3. 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 ;
          4. 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;
          5. Known hereditary or acquired bleeding and thrombotic predisposition (e.g.,
             hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
          6. 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;
          7. 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;
          8. Patients with other malignancies (except cured basal cell carcinoma of the skin and
             cervical carcinoma in situ) within the previous 3 years or concurrently;
          9. Patients with established bone metastases who have received, within 4 weeks prior to
             enrollment in the study;
         10. Prior external radiotherapy to the lesion;
         11. Pregnant or breastfeeding women, or women of childbearing age who do not wish to use
             contraception;
         12. 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.