Study of Combined Cryoablation and Thermal Ablation as a Non-Surgical Treatment for Breast Cancer in Women Evaluating Safety and Effectiveness in Patients Unable or Unwilling to Have Surgery

What this Trial Is About

Researchers are evaluating a minimally invasive treatment for breast cancer patients who cannot undergo surgery due to medical conditions or personal choice. This prospective cohort study focuses on patients diagnosed with breast cancer who are unsuitable for surgical treatment. The study aims to assess the safety and effectiveness of a combined cryo-thermal ablation system, a device developed in China that treats tumors by freezing and heating them to destroy cancerous tissue. The treatment uses a combined cold and heat ablation system guided by ultrasound, which freezes tumors to very low temperatures and then applies high-intensity heat to ablate the tissue. This method is designed to reduce bleeding and prevent tumor spread along the needle tract. Patients receive this ablation therapy as an alternative to surgery. The study enrolls patients with reasons such as intolerance to surgery, unresectable or metastatic disease, or personal refusal of surgery. Data are collected from clinical, imaging, and pathological sources during and after treatment. Participants are followed up for more than five years through telephone and digital communication tools to monitor complications within three months after treatment, such as infection or skin damage, and long-term outcomes including cancer recurrence, metastasis, and survival. The study measures safety by tracking complications and local tumor recurrence at three months and three years respectively. Secondary outcomes include disease-free survival and overall survival over three years. Researchers also explore tumor tissue response and immune function using preserved samples and imaging data.

A Cohort Study of Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients