Study of Multi-mode Thermophysical Immunotherapy vs Conventional Radiofrequency Ablation for Treating Breast Cancer Liver Metastases in Women Aged 18 to 75

What this Trial Is About

Researchers are evaluating a multi-mode integrated ablation system for treating breast cancer liver metastases in a single-center, parallel-controlled clinical study. The study aims to assess the safety, effectiveness, and impact on the bodys anti-tumor immune response of this new ablation technique compared to conventional radiofrequency ablation. Participants are women aged 18 to 75 with confirmed breast cancer liver metastases who cannot or choose not to have surgery. The trial will enroll 10 women, randomly assigned to receive either the multi-mode ablation treatment or conventional radiofrequency ablation. The multi-mode treatment involves rapid freezing of tumor tissue to form an ice ball beyond the lesion, followed by thawing and radiofrequency ablation to fully treat the tumor with a safety margin. The conventional group receives radiofrequency ablation using preset power and time settings to ensure a safety margin around the tumor. Participants undergo a screening phase, treatment phase, and follow-up period lasting up to 24 months. Researchers will monitor the anti-tumor immune response and measure local control rates, progression-free survival at 6 months and 1 year, and overall survival at 1 year. Safety and treatment effects will be assessed throughout to understand the impact of the new multi-mode ablation system compared to standard care.

A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases