Combined cryoablation and thermal ablation for non-surgical breast cancer treatment
Official title: Peking University People's Hospital Breast Surgery Department
Run by Peking University People's Hospital · NCT07238894 · Data updated 2026-11-12
This study will test whether a combined freezing and heating ablation approach can safely treat adults with biopsy-confirmed breast cancer who cannot or will not have surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | June 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07238894 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with ultrasound-visible, biopsy-confirmed breast cancer who cannot tolerate or refuse conventional surgical resection and have no contraindications to cryoablation are ideal candidates.
✕Probably not a fit
Patients who are pregnant or lactating, have contraindications to cryotherapy (for example cryoglobulinemia or implanted electronic devices), have significant missing clinical data, or are otherwise vulnerable may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective cohort drawn from the breast disease database at Peking University People's Hospital enrolling adults with core-needle-biopsy confirmed breast cancer who are unsuitable for or refuse conventional surgery. Participants receive a combined cryo-thermal ablation procedure that uses deep cryogenic freezing followed by high-intensity heating, typically performed under ultrasound guidance. Outcomes focus on procedure safety, local tumor control on imaging, and clinical follow-up with pathology when available. The device is an advanced minimally invasive system developed in China and has regulatory approval for ablation of several solid tumor types.
Why it matters
Potential benefit: If successful, the procedure could provide effective local tumor control without open surgery, avoiding general anesthesia and improving cosmetic outcomes for patients who cannot or will not undergo surgery.
How similar studies have gone: Prior small studies of cryoablation or thermal ablation alone have shown preliminary safety and local control for breast lesions, but combined cryo-thermal use for breast cancer is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
-
Peking University People's Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Shu Wang, Dr.
- Email: wangshu@163.com
- Phone: 010-88324010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.