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NOT YET RECRUITING
NCT07578506
PHASE1

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-05-01

Completion Date

2027-05-01

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

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.

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.

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.

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).

Locations (1)

Sichuan University West China Hospital, Chengdu, Sichuan

Chengdu, Sichuan, China