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RECRUITING
NCT06567353
NA

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-12-09

Completion Date

2027-12

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DEVICE

Multi-mode tumor treatment system

All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. The treatment procedure includes: rapid freezing of the tumor tissue to form an ice ball extending 5mm beyond the lesion, maintaining this state for 5 minutes, followed by thawing and rewarming; subsequently, RFA is performed to ensure complete ablation, with the ablation zone including a safety margin of 5-10mm around the tumor.

DEVICE

Radiofrequency ablation therapeutic apparatus

All subjects are treated using the radiofrequency ablation therapeutic apparatus (MedSphere International (Shanghai) Co., Ltd.), with the treatment procedure conducted according to the preset power and time parameters to ensure a safety margin of 5-10mm.

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China