Locally Recurrent Retroperitoneal Soft Tissue SarcomaPhase 1NCT07578506

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

A Phase 1 study testing Ta-NPs (2% Tumor Volume), Ta-NPs (5% Tumor Volume) and Ta-NPs (10% Tumor Volume) in people with Locally Recurrent Retroperitoneal Soft Tissue Sarcoma, run by West China Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Recurrent Retroperitoneal Soft Tissue Sarcoma
What is being tested?: Ta-NPs (2% Tumor Volume), Ta-NPs (5% Tumor Volume) and Ta-NPs (10% Tumor Volume)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteChina
Study dates: 1 May 2026to 1 May 2027
Phase: Phase 1

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

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:
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.
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:

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

Who cannot join

Presence of distant metastasis (M1 stage) that is not suitable for local radiotherapy intervention.
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).

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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).
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.
Major surgical procedure (excluding diagnostic surgery) within 4 weeks before start of treatment.
History of psychoactive substance abuse without ability to abstain, or history of psychiatric disorders.
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.
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.
Any condition that is not in the best interest of the participant.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xingchen Peng, MD, PhD contact

+8618980606753

pxx2014@163.com

China1 site

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

Other trials in China

About this study

Official title: 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.

Conditions: Locally Recurrent Retroperitoneal Soft Tissue Sarcoma
Being tested: Ta-NPs (2% Tumor Volume), Ta-NPs (5% Tumor Volume), Ta-NPs (10% Tumor Volume), Radiotherapy
Keywords: Retroperitoneal Soft Tissue Sarcoma, Radiotherapy, Radiosensitizer, Nanomaterials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ta-NPs (2% Tumor Volume)Biological
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.
Ta-NPs (5% Tumor Volume)Biological
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.
Ta-NPs (10% Tumor Volume)Biological
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.
RadiotherapyRadiation
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).

Study groups in NCT07578506
Study group	Role	What they receive
Arm 1: Low-Dose Ta-NPs (2% Tumor Volume) Plus Radiotherapy	Experimental	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. Receives: Biological: Ta-NPs (2% Tumor Volume); Radiation: Radiotherapy
Arm 2: Medium-Dose Ta-NPs (5% Tumor Volume) Plus Radiotherapy	Experimental	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. Receives: Biological: Ta-NPs (5% Tumor Volume); Radiation: Radiotherapy
Arm 3: High-Dose Ta-NPs (10% Tumor Volume) Plus Radiotherapy	Experimental	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. Receives: Biological: Ta-NPs (10% Tumor Volume); Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Dose-Limiting Toxicity (DLT)
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.
Measured: From day of Ta-NPs injection through day 28 post-injection

Secondary outcomes (7)

Incidence of Adverse Events
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.
Measured: From signing of informed consent through 90 days after last dose
Pharmacokinetics (PK) of Ta-NPs
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).
Measured: 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)
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria, assessed for injected and non-injected lesions.
Measured: 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
Proportion of participants with no disease progression (as defined by RECIST 1.1) at 6 months after intratumoral injection.
Measured: 6 months post injection
Progression-Free Survival (PFS)
Time from intratumoral injection to first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Measured: From injection until disease progression or death (up to approximately 36 months)
Overall Survival (OS)
Time from intratumoral injection to death from any cause.
Measured: From injection until death (up to approximately 36 months)
Salvage Surgery Success Rate
Proportion of participants who undergo salvage surgery after treatment and achieve complete (R0) resection.
Measured: At the time of salvage surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20261 May 2027

First posted11 May 2026
Study start1 May 2026 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion1 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Locally Recurrent Retroperitoneal Soft Tissue SarcomaStudies of the same condition, open and under way.
More trials run by West China HospitalThe sponsor's other registered studies.
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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 9 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07578506
Sponsor's protocol ID: HX 2026-937
Status last verified: May 2026
First submitted: 27 Apr 2026
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bonvalot S, Rutkowski PL, Thariat J, Carrere S, Ducassou A, Sunyach MP, Agoston P, Hong A, Mervoyer A, Rastrelli M, Moreno V, Li RK, Tiangco B, Herraez AC, Gronchi A, Mangel L, Sy-Ortin T, Hohenberger P, de Baere T, Le Cesne A, Helfre S, Saada-Bouzid E, Borkowska A, Anghel R, Co A, Gebhart M, Kantor G, Montero A, Loong HH, Verges R, Lapeire L, Dema S, Kacso G, Austen L, Moureau-Zabotto L, Servois V, Wardelmann E, Terrier P, Lazar AJ, Bovee JVMG, Le Pechoux C, Papai Z. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Aug;20(8):1148-1159. doi: 10.1016/S1470-2045(19)30326-2. Epub 2019 Jul 8.
PubMed 31296491
Leite ETT, Munhoz RR, Camargo VP, Lima LGCA, Rebolledo DCS, Maistro CEB, Busnardo FF, Ferreira FO, Salvajoli JV, Carvalho HA. Neoadjuvant stereotactic ablative radiotherapy (SABR) for soft tissue sarcomas of the extremities. Radiother Oncol. 2021 Aug;161:222-229. doi: 10.1016/j.radonc.2021.06.027. Epub 2021 Jun 22.
PubMed 34171452
Rhomberg W, Hassenstein EO, Gefeller D. Radiotherapy vs. radiotherapy and razoxane in the treatment of soft tissue sarcomas: final results of a randomized study. Int J Radiat Oncol Biol Phys. 1996 Dec 1;36(5):1077-84. doi: 10.1016/s0360-3016(96)00433-6.
PubMed 8985029
Rhomberg W. The radiation response of sarcomas by histologic subtypes: a review with special emphasis given to results achieved with razoxane. Sarcoma. 2006;2006(1):87367. doi: 10.1155/SRCM/2006/87367.
PubMed 17040092
Khokhar MA, Akhtar M, Shah Gillani SFUH, Abdulsalaam R, Qamar S. Radiotherapy alone with concurrent chemoradiotherapy plus temozolamide in locally advanced soft tissue sarcoma at Mayo Hospital Lahore: A randomized controlled trial. J Pak Med Assoc. 2020 Apr;70(4):572-576. doi: 10.5455/JPMA.293442.
PubMed 32296197
Huang Z, Li N, Tang Y, Jin J, Liu W, Xu H, Yu F, Hao L, Zhang Q, Ding Y, Niu X. Neoadjuvant radiotherapy for soft tissue sarcoma in China: a preliminary result. Ann Transl Med. 2022 Apr;10(8):452. doi: 10.21037/atm-22-98.
PubMed 35571451
Hayes AJ, Nixon IF, Strauss DC, Seddon BM, Desai A, Benson C, Judson IR, Dangoor A. UK guidelines for the management of soft tissue sarcomas. Br J Cancer. 2025 Jan;132(1):11-31. doi: 10.1038/s41416-024-02674-y. Epub 2024 May 11.
PubMed 38734790
Hogg HD, Manas DM, Lee D, Dildey P, Scott J, Lunec J, French JJ. Surgical outcome and patterns of recurrence for retroperitoneal sarcoma at a single centre. Ann R Coll Surg Engl. 2016 Mar;98(3):192-7. doi: 10.1308/rcsann.2016.0057. Epub 2016 Feb 14.
PubMed 26876538
Schwartz PB, Vande Walle K, Winslow ER, Ethun CG, Tran TB, Poultsides G, Tseng J, Roggin K, Grignol V, Howard JH, Krasnick BA, Fields RC, Mogal H, Clarke CN, Senehi R, Votanopoulos K, Cardona K, Abbott DE. Predictors of Disease-Free and Overall Survival in Retroperitoneal Sarcomas: A Modern 16-Year Multi-Institutional Study from the United States Sarcoma Collaboration (USSC). Sarcoma. 2019 Jun 2;2019:5395131. doi: 10.1155/2019/5395131. eCollection 2019.
PubMed 31281208
Buja A, Rugge M, Barillaro M, Miatton A, Tropea S, Cozzolino C, Zorzi M, Vecchiato A, Del Fiore P, Brunello A, Baldo V, Rossi CR, Mocellin S. Epidemiology, pathological characteristics and survival of retroperitoneal soft-tissue sarcomas compared with non-retroperitoneal soft tissue sarcomas. Oncol Lett. 2023 May 26;26(1):301. doi: 10.3892/ol.2023.13887. eCollection 2023 Jul.
PubMed 37323817
Ferrari A, Sultan I, Huang TT, Rodriguez-Galindo C, Shehadeh A, Meazza C, Ness KK, Casanova M, Spunt SL. Soft tissue sarcoma across the age spectrum: a population-based study from the Surveillance Epidemiology and End Results database. Pediatr Blood Cancer. 2011 Dec 1;57(6):943-9. doi: 10.1002/pbc.23252. Epub 2011 Jul 25.
PubMed 21793180
Porter GA, Baxter NN, Pisters PW. Retroperitoneal sarcoma: a population-based analysis of epidemiology, surgery, and radiotherapy. Cancer. 2006 Apr 1;106(7):1610-6. doi: 10.1002/cncr.21761.
PubMed 16518798