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

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.

Timeline

Start

2026-05-01

Primary completion

2026-12-31

Completion

2027-05-01

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.

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Indications