Locally recurrent retroperitoneal soft tissue sarcoma (dedifferentiated liposarcoma or leiomyosarcoma)
Conditions
Interventions
Low-dose group:Intratumoral injection of Ta-NPs (2% of tumor volume) + RT
Medium-dose group:Intratumoral injection of Ta-NPs (5% of tumor volume) + RT
High-dose group:Intratumoral injection of Ta-NPs (10% of tumor volume) + RT
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, no upper age limit; 2. ECOG performance status of 0 or 1; 3. Histopathologically confirmed diagnosis of dedifferentiated liposarcoma (DD-LPS) or leiomyosarcoma (LMS), with local or regional recurrence after prior standard treatment centered on curative surgery. Prior treatment includes: a) Must have received radical/wide excision surgery for the primary lesion or first recurrent lesion; b) May have received one or more of the following treatments, completed at least 4 weeks before enrollment: radiotherapy (external beam radiotherapy for the abdominopelvic region, with detailed radiotherapy plan and DVH diagram required to assess normal organ exposure); chemotherapy (anthracycline-based and/or ifosfamide-based systemic chemotherapy); targeted therapy (e.g., anlotinib, etc.); c) All acute adverse events related to prior treatments must have resolved to normal or Grade 1 according to CTCAE criteria; 4. At least one lesion suitable for intratumoral injection (e.g., injectable directly or with the aid of medical imaging instruments) and radiotherapy, with a volume = 3000 cm³ (measured by CT/MRI: length × width × height; tumor volume formula = length × width × height) and clearly assessable by imaging; 5. Within 7 days before the first dose, adequate hematologic and end-organ function, meeting the following laboratory criteria: a) Hematology: No granulocyte colony-stimulating factor (G-CSF) use within 14 days before hematology lab tests, and absolute neutrophil count (ANC) >= 1.5 × 10?/L; No platelet transfusion within 14 days before hematology lab tests, and platelet count (PLT) >= 90 × 10?/L; No blood transfusion or erythropoietin use within 14 days before hematology lab tests, and hemoglobin (Hb) >= 90 g/L. b) Renal function: Serum creatinine (Cr) = 50 mL/min using the Cockcroft-Gault formula (Ccr calculated only when baseline Cr > 1.5 × ULN). c) Liver function: Total bilirubin (TBIL) = 1.5 × ULN (= 2.8 g/dL. d) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) = 50%; 6. Expected survival >= 6 months; 7. Subjects voluntarily participate in the study, sign informed consent, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of distant metastasis (M1 stage) that is not suitable for local radiotherapy intervention; 2. Active skin breakdown, infection, ulcer, necrosis, or bleeding at the injection site, or risk of hollow organ perforation; 3. Prior radiotherapy to the target lesion area within the past 6 months; 4. Known allergy or intolerance to the active ingredient, excipients, or similar nanoparticles of Ta-NPs; 5. Pregnant or breastfeeding women; subjects (and their partners) who have a fertility plan, engage in unprotected sexual intercourse, or are unwilling to take appropriate contraceptive measures (e.g., condoms, intrauterine devices, or partner sterilization) from the screening period until 3 months after the end of the study; 6. HIV positive; HCV positive; HBsAg or HBcAb positive with detectable HBV DNA copy number (quantitative detection = 500 IU/ml); 7. Active pulmonary tuberculosis, or a history of pulmonary tuberculosis infection that has not been controlled after treatment; 8. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes mellitus, cardiovascular diseases (New York Heart Association class III or IV heart failure, second-degree or higher atrioventricular block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within the past 3 months, etc.), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and history of symptomatic bronchospasm); 9. Subjects with active central nervous system (CNS) metastases are excluded. Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if they have received treatment and have no evidence of disease progression on magnetic resonance imaging for at least 8 weeks after treatment completion and within 28 days before the first dose. Additionally, systemic corticosteroids at immunosuppressive doses (>10 mg/day prednisone equivalent) must not be required for at least 2 weeks before study drug administration; 10. Major surgery (excluding diagnostic surgery) performed within 4 weeks before the start of treatment; 11. History of substance abuse (psychoactive drugs) that cannot be abstained from, or history of mental disorders; 12. Other malignancies within the past 5 years that have not been cured, excluding obviously cured malignancies or curable cancers such as basal cell or squamous cell skin cancer, superficial bladder cancer or prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ; 13. Any other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator’s opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results; 14. Any condition that is not in the best interest of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;Treatment?Emergent Adverse Event (TEAE);Grade >=3 Treatment?Related Adverse Event (TRAE);Serious Adverse Event;Pharmacokinetics (PK): Concentration of tantalum in whole blood, plasma, and urine;Objective Response Rate;Progression-Free Survival;Overall Survival;Salvage surgery success rate (R0 resection rate); | — |
Countries
China
Contacts
Public ContactXingchen Peng
West China Hospital, Sichuan University
Outcome results
None listed