RecruitingNot ApplicableNCT06567353

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


Sponsor

Ruijin Hospital

Enrollment

10 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of heat-based and immune-boosting treatments for breast cancer that has spread to the liver. It is designed for patients who cannot or do not want to have surgery to remove the liver tumors. **You may be eligible if:** - You are a woman between 18 and 75 years old - Your breast cancer has spread to the liver and surgery is not an option - You have no more than 3 liver tumors, each smaller than 4 cm - Your liver function is reasonably good (Child-Pugh class A or B) - It has been at least 1 month since your last local treatment - You are in fair general health (ECOG score 2 or lower) with a life expectancy over 3 months **You may NOT be eligible if:** - Your liver is severely damaged (Child-Pugh class C) - Your cancer has spread widely and your life expectancy is less than 3 months - You had bleeding from esophageal varices in the past month - You have major organ failure, active infection, or severe fluid buildup - You are pregnant or unable to cooperate with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMulti-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.

DEVICERadiofrequency 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06567353


Related Trials