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

Recruiting now · Not applicable

Conditions studied: Ablation, Breast Cancer

In brief

Although surgical resection is the gold standard for early breast cancer treatment, some patients cannot tolerate surgery due to medical conditions or refuse surgical treatment for cosmetic reasons. In recent years, the rapid development of ablation technology has provided new directions for breast cancer patients who are not suitable for surgical treatment. Ablation uses high or low temperatures to deactivate lesions or tissues, which are gradually absorbed by the body, achieving local treatment purposes. Its safety and efficacy have been preliminarily confirmed. As an advanced minimally invasive medical device independently developed in China, the combined cryo-thermal ablation system treats tumors using a combined mode of deep cryogenic freezing and high-intensity heating. It has been approved for ablation treatment of various solid tumors including lung cancer, pancreatic cancer, kidney cancer, prostate cancer, breast cancer, bone and soft tissue sarcomas. This project proposes a prospective cohort design, based on the breast disease cohort database of Peking University People's Hospital Breast Center. It will enroll patients pathologically diagnosed with breast cancer, determined unsuitable for surgical treatment, and have received combined cryo-thermal ablation. The registered data will be used to evaluate the effectiveness and safety of percutaneous ultrasound-guided cryo-thermal composite ablation in this population.

Key facts

Study ID

NCT07238894

Run by

Peking University People's Hospital

People needed

200

Starts

2026-03-03

Expected to finish

2028-10-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 1) Aged 18 or above; 2) Breast cancer confirmed by core needle biopsy; 3) Tumor lesions clearly visible on ultrasound; 4) No contraindications for cryoablation such as coagulation disorders; 5) Presence of reasons unsuitable for conventional surgical resection: patient's condition cannot tolerate general anesthesia or surgical treatment; due to unresectable and/or metastatic disease; patient refuses surgery, etc.; 6) Agree to undergo ablation surgery and sign the consent form.

You may not qualify if…

• 1) Missing clinical and pathological data (such as imaging and pathological materials); 2) Pregnant or lactating women; 3) Known allergies, intolerances, or contraindications to cryotherapy (such as cryoglobulinemia, presence of implanted electronic devices); 4) Vulnerable populations, including those with neurological disorders, cognitive impairments, critically ill patients, etc.

Where it is running

• Peking University People's Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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