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

NCT07238894 | Recruiting

• 1 other identifier: PKUPHBC202509
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ablation; Breast Cancer

Keywords

Combined Cryoablation and Thermal Ablation

Outcome Measures

Primary Outcomes (2)

• Ipsilateral breast cancer recurrence

  From the surgery date to the ipsilateral breast tumor recurrence date

  3 years

• the rate of comlications

  The proportion of complications occurring during surgery and within 3 months after surgery

  3 months

Secondary Outcomes (2)

• disease free survival

  3 years

• overall survival

  3 years

Other Outcomes (1)

• exploratory research

  1 year

Study Arms (1)

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

EXPERIMENTAL

Device: Combined Cryoablation and Thermal Ablation system

Interventions

Combined Cryoablation and Thermal Ablation system DEVICE

The combined cold and heat ablation system, as an advanced minimally invasive medical device for tumors independently developed in China, adopts a combined mode of deep low-temperature cryotherapy and high-intensity heating to treat tumors. This system uses liquid nitrogen as the refrigerant, which is easy to obtain. The minimum freezing temperature can reach -196℃, and the single-needle ablation range is larger. Using anhydrous ethanol as the heat medium, the ablation needle can be heated to 80℃ after freezing, which can dissolve ice balls more quickly. At the same time, it can ablate the puncture needle tract, reduce bleeding, prevent tumor needle tract implantation and metastasis, and has higher safety.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female breast cancer patient
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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:

• \) 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100000, China

RECRUITING

Related Publications (12)

• Yang W, An Y, Li Q, Liu C, Zhu B, Huang Q, Zhao M, Yang F, Feng H, Hu K. Co-ablation versus cryoablation for the treatment of stage III-IV non-small cell lung cancer: A prospective, noninferiority, randomized, controlled trial (RCT). Thorac Cancer. 2021 Feb;12(4):475-483. doi: 10.1111/1759-7714.13779. Epub 2020 Dec 14.

  PMID: 33319493 RESULT

• Wang YF, Li XG. Co-ablation of lung malignancies with coexisting usual interstitial pneumonia: a retrospective analysis of safety and efficacy. Int J Hyperthermia. 2025 Dec;42(1):2468764. doi: 10.1080/02656736.2025.2468764. Epub 2025 Feb 23.

  PMID: 39988332 RESULT

• Fine RE, Gilmore RC, Tomkovich KR, Dietz JR, Berry MP, Hernandez LE, Columbus KS, Seedman SA, Fisher CS, Han LK, Manahan ER, Hicks RD, Vaidya RP, Curcio LD, Sevrukov AB, Kenler AS, Taback B, Chen M, Miller ME, Gold L, Anglin BV, Aoun HD, Simmons RM, Feldman SM, Boolbol SK. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. 2024 Oct;31(11):7273-7283. doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16.

  PMID: 39283572 RESULT

• Fine RE, Gilmore RC, Dietz JR, Boolbol SK, Berry MP, Han LK, Kenler AS, Sabel M, Tomkovich KR, VanderWalde NA, Chen M, Columbus KS, Curcio LD, Feldman SM, Gold L, Hernandez L, Manahan ER, Seedman SA, Vaidya RP, Sevrukov AB, Aoun HD, Hicks RD, Simmons RM. Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial. Ann Surg Oncol. 2021 Oct;28(10):5525-5534. doi: 10.1245/s10434-021-10501-4. Epub 2021 Aug 15.

  PMID: 34392462 RESULT

• van de Voort EMF, Struik GM, Birnie E, Moelker A, Verhoef C, Klem TMAL. Thermal Ablation as an Alternative for Surgical Resection of Small (</= 2 cm) Breast Cancers: A Meta-Analysis. Clin Breast Cancer. 2021 Dec;21(6):e715-e730. doi: 10.1016/j.clbc.2021.03.004. Epub 2021 Mar 17.

  PMID: 33840627 RESULT

• Wang YQ, Tan ZK, Peng Z, Huang H. A systematic review and meta-analysis of the comparison of laparoscopic radiofrequency ablation to percutaneous radiofrequency ablation for hepatocellular carcinoma. Front Oncol. 2025 Mar 11;15:1559343. doi: 10.3389/fonc.2025.1559343. eCollection 2025.

  PMID: 40134600 RESULT

• Azizi M, Heshmatnia F, Milani H, Shahhosseini Z, Marvdashti LM, Moghadam ZB. The Effectiveness of Cognitive Behavioral Therapy on Depression and Anxiety Symptoms in Breast Cancer Patients and Survivors: A Systematic Review of Interventional Studies. Brain Behav. 2024 Oct;14(10):e70098. doi: 10.1002/brb3.70098.

  PMID: 39467209 RESULT

• Divani A, Heidari ME, Ghavampour N, Parouhan A, Ahmadi S, Narimani Charan O, Shahsavari H. Effect of cancer treatment on sleep quality in cancer patients: A systematic review and meta-analysis of Pittsburgh Sleep Quality Index. Support Care Cancer. 2022 Jun;30(6):4687-4697. doi: 10.1007/s00520-021-06767-9. Epub 2022 Jan 26.

  PMID: 35079904 RESULT

• Ziegler P, Hartkopf AD, Wallwiener M, Haberle L, Kolberg HC, Hadji P, Tesch H, Ettl J, Luftner D, Muller V, Michel LL, Belleville E, Wimberger P, Hielscher C, Huebner H, Uhrig S, Wurmthaler LA, Hack CC, Mundhenke C, Kurbacher C, Fasching PA, Wuerstlein R, Untch M, Janni W, Taran FA, Lux MP, Wallwiener D, Brucker SY, Fehm TN, Schneeweiss A, Goossens C. The impact of physical activity on progression-free and overall survival in metastatic breast cancer based on molecular subtype. BMC Cancer. 2024 Oct 16;24(1):1284. doi: 10.1186/s12885-024-13038-3.

  PMID: 39415149 RESULT

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 RESULT

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

• Kim J, Harper A, McCormack V, Sung H, Houssami N, Morgan E, Mutebi M, Garvey G, Soerjomataram I, Fidler-Benaoudia MM. Global patterns and trends in breast cancer incidence and mortality across 185 countries. Nat Med. 2025 Apr;31(4):1154-1162. doi: 10.1038/s41591-025-03502-3. Epub 2025 Feb 24.

  PMID: 39994475 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Shu Wang, Dr.

CONTACT

010-88324010; wangshu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)