AblationNCT07238894
A Cohort Study of Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients
A study testing Combined Cryoablation and Thermal Ablation system in people with Ablation and Breast Cancer, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ablation, Breast Cancer
- What is being tested?
- Combined Cryoablation and Thermal Ablation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100000
Shu Wang, Dr., 01088324010, wangshu@163.com
About this study
Official title: Peking University People's Hospital Breast Surgery Department
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.
Read the detailed description
- Study Design
- Prospective Cohort Study Study Subjects and Selection Criteria
- This study is based on the breast disease cohort database of Peking University People's Hospital Breast Center. Patients with pathologically confirmed breast cancer who refused, were intolerant of, or unsuitable for surgical treatment and received combined cryoablation and thermal ablation were prospectively enrolled.
The specific inclusion and exclusion criteria are as follows:
- Inclusion Criteria (all conditions must be met): ≥18 years old; Breast cancer confirmed by core needle biopsy; Tumor lesions clearly visible on ultrasound; No contraindications for cryoablation such as coagulation disorders; Presence of reasons unsuitable for conventional surgical resection: Patients intolerant to general anesthesia or surgical treatment due to medical conditions; Due to unresectable and/or metastatic disease; Patient refusal of surgery, etc.; Agree to undergo ablation surgery and sign the informed consent form.
- Exclusion Criteria (Participants will be excluded if any of the following apply):
Missing clinical and pathological data (such as imaging or pathological materials); Pregnant or lactating women; Known allergies, intolerance, or contraindications to cryotherapy (such as cryoglobulinemia, presence of implanted electronic devices); Vulnerable populations, including those with neurological disorders, cognitive impairments, critically ill patients, etc.
3)Grouping of Study Subjects This study is a prospective cohort study. The decision to undergo combined cold and heat ablation therapy was made through mutual consultation between patients and attending physicians, while the remaining systemic treatments were not affected by the study.Cohort 1: Ablation therapy for patients who cannot tolerate standard surgery due to advanced age or comorbidities;Cohort 2: Ablation therapy for patients with unresectable/metastatic diseases who are not suitable for surgical resection;Cohort 3: Ablation therapy chosen by patients who refuse surgical treatment for personal reasons.
4)Research Steps Screen patients who meet the inclusion criteria and exclude those who meet the exclusion criteria.
Collect patients' clinicopathological data: age, menstrual status, accompanying diseases; tumor imaging information, including ultrasound, mammography, MRI reports, tumor size, and axillary lymph node status; pathological information, including pathological type, histological grade, hormone receptor status, and postoperative adjuvant treatment plans.
Breast primary tumors receive standard combined cryoablation and thermal ablation treatment, and collect imaging and histological laboratory data during and after treatment.
Retrieve patients' prognosis information from the follow-up database, including recurrence, metastasis, second primary tumor, and mortality events.
5)Follow-up Plan and Contents:
Postoperative Complications (within 3 months):
Skin damage Poor incision healing Infection Seroma formation Nipple or flap ischemia/necrosis
Survival-related Follow-up:
Recurrence Metastasis Second primary tumor Mortality events
Follow-up Methods:
Telephone WeChat client of Peking University People's Hospital Follow-up System Follow-up Interval: 6 months Follow-up Duration: More than 5 years 6)Selection and Confirmation of Primary Measurement Indicators or Outcome Measures
Primary Study Endpoint - Safety:
Intraoperative complications (e.g., bleeding, vascular/nerve injury) Postoperative complications (infection, hematoma, frostbite, breast deformity, paresthesia, etc.), recorded according to CTCAE v5.0 classification Local tumor recurrence rate (Ipsilateral Breast Cancer Recurrence, IBTR): defined as the time from surgery to ipsilateral breast tumor recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event
Secondary Study Endpoints:
Disease-free survival (DFS): time from study enrollment to the first occurrence of failure events, including ipsilateral local-regional recurrence, contralateral breast cancer, distant recurrence, or death from any cause Overall survival (OS): time from study enrollment to death from any cause Exploratory analysis: using specimen bank preserved samples and imaging data to analyze post-ablation tumor tissue pathological response, blood immune function assessment, and the correlation between postoperative imaging (MRI/ultrasound) characteristics and recurrence risk All data collection is sourced from the established Peking University People's Hospital Breast Disease Cohort Database (PKUPH Breast Disease Cohort).
7)The primary study outcome was a local IBTR at 5 years through the width of the 95% confidence interval (CI). A sample size was calculated for this outcome. For a two-sided 95% exact Clopper Pearson confidence interval of the IBTR rate whose true value was 5%, a sample size of 200 patients was required to yield a half-width of 5% at most with more than 99% power. In this context, power is the probability (conditional method) of obtaining a confidence interval a half-width less than or equal to the hypothesized value.
- Conditions
- Ablation, Breast Cancer
- Being tested
- Combined Cryoablation and Thermal Ablation system
- Keywords
- Combined Cryoablation and Thermal Ablation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Cryoablation and Thermal Ablation systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients | Experimental | Not described Receives: Device: Combined Cryoablation and Thermal Ablation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral breast cancer recurrence
From the surgery date to the ipsilateral breast tumor recurrence date
Measured: 3 years
the rate of comlications
The proportion of complications occurring during surgery and within 3 months after surgery
Measured: 3 months
Secondary outcomes (2)
disease free survival
The time from enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.
Measured: 3 years
overall survival
The time from enrollment to death caused by any reason.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start3 Mar 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AblationStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238894
- Sponsor's protocol ID
- PKUPHBC202509
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33319493Wang 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.
PubMed 39988332Fine 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.
PubMed 39283572Fine 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.
PubMed 34392462van 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.
PubMed 33840627Wang 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.
PubMed 40134600Azizi 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.
PubMed 39467209Divani 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.
PubMed 35079904Ziegler 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.
PubMed 39415149Bray 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.
PubMed 38572751Sung 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.
PubMed 33538338Kim 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.
PubMed 39994475
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University People's Hospital Breast Surgery Department
- ClinicalTrials.gov ID
- NCT07238894
- Acronym / sponsor ID
- PKUPHBC202509
- Conditions
- Ablation, Breast Cancer
- Keywords
- Combined Cryoablation and Thermal Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study Design
- Prospective Cohort Study Study Subjects and Selection Criteria
- This study is based on the breast disease cohort database of Peking University People's Hospital Breast Center. Patients with pathologically confirmed breast cancer who refused, were intolerant of, or unsuitable for surgical treatment and received combined cryoablation and thermal ablation were prospectively enrolled.
The specific inclusion and exclusion criteria are as follows:
- Inclusion Criteria (all conditions must be met): ≥18 years old; Breast cancer confirmed by core needle biopsy; Tumor lesions clearly visible on ultrasound; No contraindications for cryoablation such as coagulation disorders; Presence of reasons unsuitable for conventional surgical resection: Patients intolerant to general anesthesia or surgical treatment due to medical conditions; Due to unresectable and/or metastatic disease; Patient refusal of surgery, etc.; Agree to undergo ablation surgery and sign the informed consent form.
- Exclusion Criteria (Participants will be excluded if any of the following apply):
Missing clinical and pathological data (such as imaging or pathological materials); Pregnant or lactating women; Known allergies, intolerance, or contraindications to cryotherapy (such as cryoglobulinemia, presence of implanted electronic devices); Vulnerable populations, including those with neurological disorders, cognitive impairments, critically ill patients, etc.
3)Grouping of Study Subjects This study is a prospective cohort study. The decision to undergo combined cold and heat ablation therapy was made through mutual consultation between patients and attending physicians, while the remaining systemic treatments were not affected by the study.Cohort 1: Ablation therapy for patients who cannot tolerate standard surgery due to advanced age or comorbidities;Cohort 2: Ablation therapy for patients with unresectable/metastatic diseases who are not suitable for surgical resection;Cohort 3: Ablation therapy chosen by patients who refuse surgical treatment for personal reasons.
4)Research Steps Screen patients who meet the inclusion criteria and exclude those who meet the exclusion criteria.
Collect patients' clinicopathological data: age, menstrual status, accompanying diseases; tumor imaging information, including ultrasound, mammography, MRI reports, tumor size, and axillary lymph node status; pathological information, including pathological type, histological grade, hormone receptor status, and postoperative adjuvant treatment plans.
Breast primary tumors receive standard combined cryoablation and thermal ablation treatment, and collect imaging and histological laboratory data during and after treatment.
Retrieve patients' prognosis information from the follow-up database, including recurrence, metastasis, second primary tumor, and mortality events.
5)Follow-up Plan and Contents:
Postoperative Complications (within 3 months):
Skin damage Poor incision healing Infection Seroma formation Nipple or flap ischemia/necrosis
Survival-related Follow-up:
Recurrence Metastasis Second primary tumor Mortality events
Follow-up Methods:
Telephone WeChat client of Peking University People's Hospital Follow-up System Follow-up Interval: 6 months Follow-up Duration: More than 5 years 6)Selection and Confirmation of Primary Measurement Indicators or Outcome Measures
Primary Study Endpoint - Safety:
Intraoperative complications (e.g., bleeding, vascular/nerve injury) Postoperative complications (infection, hematoma, frostbite, breast deformity, paresthesia, etc.), recorded according to CTCAE v5.0 classification Local tumor recurrence rate (Ipsilateral Breast Cancer Recurrence, IBTR): defined as the time from surgery to ipsilateral breast tumor recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event
Secondary Study Endpoints:
Disease-free survival (DFS): time from study enrollment to the first occurrence of failure events, including ipsilateral local-regional recurrence, contralateral breast cancer, distant recurrence, or death from any cause Overall survival (OS): time from study enrollment to death from any cause Exploratory analysis: using specimen bank preserved samples and imaging data to analyze post-ablation tumor tissue pathological response, blood immune function assessment, and the correlation between postoperative imaging (MRI/ultrasound) characteristics and recurrence risk All data collection is sourced from the established Peking University People's Hospital Breast Disease Cohort Database (PKUPH Breast Disease Cohort).
7)The primary study outcome was a local IBTR at 5 years through the width of the 95% confidence interval (CI). A sample size was calculated for this outcome. For a two-sided 95% exact Clopper Pearson confidence interval of the IBTR rate whose true value was 5%, a sample size of 200 patients was required to yield a half-width of 5% at most with more than 99% power. In this context, power is the probability (conditional method) of obtaining a confidence interval a half-width less than or equal to the hypothesized value.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients | Experimental | Device: Combined Cryoablation and Thermal Ablation system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Cryoablation and Thermal Ablation systemThe 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. | Device | Combined Cryoablation and Thermal Ablation for Non-surgical Treatment of Breast Cancer Patients |
Primary outcome
Ipsilateral breast cancer recurrence
Time frame: 3 years
From the surgery date to the ipsilateral breast tumor recurrence date
the rate of comlications
Time frame: 3 months
The proportion of complications occurring during surgery and within 3 months after surgery
2 secondary outcomes
disease free survival
Time frame: 3 years
overall survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 33319493Yang 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.
- Results publication: PubMed 39988332Wang 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.
- Results publication: PubMed 39283572Fine 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.
- Results publication: PubMed 34392462Fine 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.
- Results publication: PubMed 33840627van 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.
- Results publication: PubMed 40134600Wang 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.
- Results publication: PubMed 39467209Azizi 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.
- Results publication: PubMed 35079904Divani 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.
- Results publication: PubMed 39415149Ziegler 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.
- Results publication: PubMed 38572751Bray 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.
- Results publication: PubMed 33538338Sung 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.
- Results publication: PubMed 39994475Kim 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Cryoablation and Thermal Ablation system in people with Ablation and Breast Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu Wang, Dr. (010-88324010, wangshu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral breast cancer recurrence (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07238894, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.