A Study of Ta-NPs Plus Radiotherapy for Locally Recurrent Retroperitoneal Sarcoma

May 5, 2026 updated by: Xingchen Peng, West China Hospital

Ta-NPs Combined With Radiotherapy for Locally Recurrent Retroperitoneal Soft Tissue Sarcoma: A Prospective, Single-Arm Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xingchen Peng, MD, PhD
  • Phone Number: +8618980606753
  • Email: pxx2014@163.com

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan University West China Hospital, Chengdu, Sichuan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years, male or female.
  2. Eastern Cooperative Oncology Group (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 with curative intent. Prior treatment must include:

    a) Curative/radical or extended resection of the primary or first recurrent lesion. b) Possible prior treatments (if received) must be completed at least 4 weeks before enrollment, including: radiotherapy (external beam radiotherapy to the abdominopelvic region; detailed radiotherapy plan and DVH must be available to assess normal organ doses), chemotherapy (anthracycline- and/or ifosfamide-based systemic chemotherapy), or targeted therapy (e.g., anlotinib). c) All acute adverse events from prior treatments must have resolved to normal or Grade 1 per CTCAE.

  4. 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.

  5. Adequate hematologic and organ function within 7 days before first dose, meeting the following laboratory criteria:

    1. 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.
    2. 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).
    3. 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.
    4. Coagulation: International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5×ULN.
    5. Cardiac: Left ventricular ejection fraction (LVEF) ≥50%.
  6. Expected survival ≥6 months.
  7. Willing and able to provide written informed consent, good compliance, and able to complete follow-up.

Exclusion Criteria:

  1. Presence of distant metastasis (M1 stage) that is not suitable for local radiotherapy intervention.
  2. Active skin ulceration, infection, erosion, necrosis, bleeding at the injection site, or risk of hollow organ perforation.
  3. The target lesion(s) have received radiotherapy within the past 6 months.
  4. Known allergy or intolerance to the active ingredient or excipients of Ta-NPs or similar nanoparticles.
  5. 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.
  6. HIV-positive; HCV-positive; HBsAg-positive or HBcAb-positive with detectable HBV DNA (quantitative assay ≥500 IU/mL).
  7. Active pulmonary tuberculosis, or history of pulmonary tuberculosis that has not been controlled after treatment.
  8. 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).
  9. Active central nervous system (CNS) metastases or leptomeningeal disease. Subjects with treated brain metastases may be eligible if there is no evidence of progression on MRI for at least 8 weeks after treatment and within 28 days before first dose, and if systemic corticosteroids (>10 mg prednisone equivalent/day) are not required for at least 2 weeks before study drug administration.
  10. Major surgical procedure (excluding diagnostic surgery) within 4 weeks before start of treatment.
  11. History of psychoactive substance abuse without ability to abstain, or history of psychiatric disorders.
  12. History of other malignancies within the past 5 years, except those that have been clearly cured or are curable, 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 condition or laboratory abnormality 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Low-Dose Ta-NPs (2% Tumor Volume) Plus Radiotherapy
Participants in this arm receive a single intratumoral injection of Ta-NPs at a concentration of 30 mg/mL, with the injection volume calculated as 2% of the baseline tumor volume . Injection is performed under imaging guidance (ultrasound or CT) prior to radiotherapy. Radiotherapy starts 24 hours after injection. Dose-limiting toxicity (DLT) is monitored during the first 28 days after Ta-NPs injection.
Biological: Ta-NPs (2% Tumor Volume)
Ta-NPs at a concentration of 30 mg/mL administered via intratumoral injection at a volume equal to 2% of the baseline tumor volume (calculated as length × width × height). Injection is performed under imaging guidance (ultrasound/CT) prior to radiotherapy.
Radiation: Radiotherapy
External beam radiotherapy delivered using a medical linear accelerator (energy ≥6 MV X-ray) with image-guided radiotherapy (IGRT). Techniques include intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Total dose follows NCCN/CSCO guidelines for soft tissue sarcoma. Fractionation: conventional fractionation (1.8-2.0 Gy per fraction, once daily, 5 days per week).
Experimental: Arm 2: Medium-Dose Ta-NPs (5% Tumor Volume) Plus Radiotherapy
Participants in this arm receive a single intratumoral injection of Ta-NPs at a concentration of 30 mg/mL, with the injection volume calculated as 5% of the baseline tumor volume . Injection is performed under imaging guidance (ultrasound or CT) prior to radiotherapy. Radiotherapy starts 24 hours after injection. Dose-limiting toxicity (DLT) is monitored during the first 28 days after Ta-NPs injection.
Radiation: Radiotherapy
External beam radiotherapy delivered using a medical linear accelerator (energy ≥6 MV X-ray) with image-guided radiotherapy (IGRT). Techniques include intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Total dose follows NCCN/CSCO guidelines for soft tissue sarcoma. Fractionation: conventional fractionation (1.8-2.0 Gy per fraction, once daily, 5 days per week).
Biological: Ta-NPs (5% Tumor Volume)
Ta-NPs at a concentration of 30 mg/mL administered via intratumoral injection at a volume equal to 5% of the baseline tumor volume (calculated as length × width × height). Injection is performed under imaging guidance (ultrasound/CT) prior to radiotherapy.
Experimental: Arm 3: High-Dose Ta-NPs (10% Tumor Volume) Plus Radiotherapy
Participants in this arm receive a single intratumoral injection of Ta-NPs at a concentration of 30 mg/mL, with the injection volume calculated as 10% of the baseline tumor volume . Injection is performed under imaging guidance (ultrasound or CT) prior to radiotherapy. Radiotherapy starts 24 hours after injection. Dose-limiting toxicity (DLT) is monitored during the first 28 days after Ta-NPs injection.
Radiation: Radiotherapy
External beam radiotherapy delivered using a medical linear accelerator (energy ≥6 MV X-ray) with image-guided radiotherapy (IGRT). Techniques include intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Total dose follows NCCN/CSCO guidelines for soft tissue sarcoma. Fractionation: conventional fractionation (1.8-2.0 Gy per fraction, once daily, 5 days per week).
Biological: Ta-NPs (10% Tumor Volume)
Ta-NPs at a concentration of 30 mg/mL administered via intratumoral injection at a volume equal to 10% of the baseline tumor volume (calculated as length × width × height). Injection is performed under imaging guidance (ultrasound/CT) prior to radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose-Limiting Toxicity (DLT)
Time Frame: From day of Ta-NPs injection through day 28 post-injection
DLT is defined as any adverse event occurring during the DLT observation period (from the first intratumoral injection of Ta-NPs through Day 28 post-injection) that is judged by the investigator to be at least possibly related to Ta-NPs and meets prespecified DLT criteria.
From day of Ta-NPs injection through day 28 post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: From signing of informed consent through 90 days after last dose
Incidence, severity, and causality of adverse events (AEs), treatment-emergent AEs (TEAEs), Grade ≥3 treatment-related AEs (TRAEs), serious AEs (SAEs), and injection site toxicity (including extravasation) assessed by CTCAE v6.0.
From signing of informed consent through 90 days after last dose
Pharmacokinetics (PK) of Ta-NPs
Time Frame: Blood: Day 0 (pre-injection, 0 hour), and at 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, Day 4, Day 8, Day 15, Day 28; Urine: Collected in intervals: 0-6 hours, 6-12 hours, 12-24 hours (Day 1), Day 2, Day 8, Day 15
Concentration-time profiles and derived PK parameters of tantalum element in whole blood, plasma, and urine after intratumoral injection of Ta-NPs, measured by inductively coupled plasma mass spectrometry (ICP-MS).
Blood: Day 0 (pre-injection, 0 hour), and at 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, Day 4, Day 8, Day 15, Day 28; Urine: Collected in intervals: 0-6 hours, 6-12 hours, 12-24 hours (Day 1), Day 2, Day 8, Day 15
Objective Response Rate (ORR)
Time Frame: Assessed at Week 3 (±2 days) after start of treatment, at treatment completion, and at Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Month 24 post-treatment initiation.
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, assessed for injected and non-injected lesions.
Assessed at Week 3 (±2 days) after start of treatment, at treatment completion, and at Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Month 24 post-treatment initiation.
Local Control Rate at 6 Months
Time Frame: 6 months post injection
Proportion of participants with no disease progression (as defined by RECIST 1.1) at 6 months after intratumoral injection.
6 months post injection
Progression-Free Survival (PFS)
Time Frame: From injection until disease progression or death (up to approximately 36 months)
Time from intratumoral injection to first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
From injection until disease progression or death (up to approximately 36 months)
Overall Survival (OS)
Time Frame: From injection until death (up to approximately 36 months)
Time from intratumoral injection to death from any cause.
From injection until death (up to approximately 36 months)
Salvage Surgery Success Rate
Time Frame: At the time of salvage surgery
Proportion of participants who undergo salvage surgery after treatment and achieve complete (R0) resection.
At the time of salvage surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Tumor Immune Microenvironment
Time Frame: Baseline (pre-treatment) and post-treatment (at time of salvage surgery or biopsy if clinically indicated)
Dynamic changes in key immune cell subsets (e.g., CD8+ T cells) within the tumor microenvironment before and after combination treatment, assessed by multiplex immunofluorescence.
Baseline (pre-treatment) and post-treatment (at time of salvage surgery or biopsy if clinically indicated)
Changes in Peripheral Blood Immune Profile
Time Frame: Baseline (pre-injection), Day 8, Day 15, Day 29, and at treatment completion
Dynamic changes in peripheral blood immune cell subsets (e.g., CD8+ T cells) measured by flow cytometry, and changes in serum cytokine levels (e.g., IFN-γ, TNF-α, IL-6) measured by ELISA.
Baseline (pre-injection), Day 8, Day 15, Day 29, and at treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX 2026-937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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