A Study of Ta-NPs Plus Radiotherapy for Locally Recurrent Retroperitoneal Sarcoma (NCT07578506) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of Ta-NPs Plus Radiotherapy for Locally Recurrent Retroperitoneal Sarcoma
China9 participantsStarted 2026-05-01
Plain-language summary
This prospective, single-arm, open-label phase I study evaluates the safety and tolerability of intratumoral injection of tantalum nanoparticles (Ta-NPs) followed by radiotherapy in patients with locally recurrent retroperitoneal soft tissue sarcoma. Using a standard 3+3 dose-escalation design, three dose levels of Ta-NPs (injection volumes of 2%, 5%, and 10% of tumor volume, all at 30 mg/mL) are tested in sequential cohorts to identify dose-limiting toxicities.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years, male or female.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Histopathologically confirmed diagnosis of dedifferentiated liposarcoma (DD-LPS) or leiomyosarcoma (LMS) with local or regional recurrence after prior standard treatment with curative intent. Prior treatment must include:
✓. At least one lesion suitable for intratumoral injection (either directly or under imaging guidance) and radiotherapy, with a volume ≤3000 cm³ (tumor volume = length × width × height measured by CT/MRI), and measurable by imaging.
✓. Adequate hematologic and organ function within 7 days before first dose, meeting the following laboratory criteria:
✓. Hematology (without G-CSF within 14 days): Absolute neutrophil count (ANC) ≥1.5×10\^9/L; (without platelet transfusion within 14 days): Platelet count (PLT) ≥90×10\^9/L; (without red blood cell transfusion or erythropoietin within 14 days): Hemoglobin (Hb) ≥90 g/L.
✓. Renal function: Serum creatinine (Cr) ≤1.5×upper limit of normal (ULN), or calculated creatinine clearance (Cockcroft-Gault) ≥50 mL/min (only required if baseline Cr \>1.5×ULN).
✓. Liver function: Total bilirubin (TBIL) ≤1.5×ULN (or ≤3.0×ULN for Gilbert's syndrome or liver metastases); AST, ALT, and alkaline phosphatase (ALP) ≤2.5×ULN; serum albumin ≥2.8 g/dL.
Exclusion criteria
✕. Presence of distant metastasis (M1 stage) that is not suitable for local radiotherapy intervention.
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: From day of Ta-NPs injection through day 28 post-injection
. Active skin ulceration, infection, erosion, necrosis, bleeding at the injection site, or risk of hollow organ perforation.
✕. The target lesion(s) have received radiotherapy within the past 6 months.
✕. Known allergy or intolerance to the active ingredient or excipients of Ta-NPs or similar nanoparticles.
✕. Pregnant or breastfeeding women; subjects (or their partners) who plan to become pregnant or have unprotected sexual intercourse without appropriate contraceptive measures (e.g., condoms, intrauterine devices, or partner sterilization) from screening through 3 months after study completion.
✕. HIV-positive; HCV-positive; HBsAg-positive or HBcAb-positive with detectable HBV DNA (quantitative assay ≥500 IU/mL).
✕. Active pulmonary tuberculosis, or history of pulmonary tuberculosis that has not been controlled after treatment.
✕. Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interfere with interpretation of results, including active opportunistic or progressive (severe) infection, uncontrolled diabetes mellitus, cardiovascular disease (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, cerebral infarction within 3 months, etc.), or pulmonary disease (interstitial pneumonia, obstructive lung disease, symptomatic bronchospasm history).