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Background Information

The China-Japan Friendship Hospital's General Surgery and Thyroid and Breast Surgery is conducting a "Non-randomized controlled clinical study of Co-Ablation System cryoablation and breast-conserving surgery in the treatment of early-stage low-risk breast cancer". This study has been approved by the Ethics Committee of the China-Japan Friendship Hospital. Volunteers who volunteered to participate in the study are now being recruited.

Early Stage Breast Cancer

The latest data released by the World Health Organization's International Agency for Research on Cancer shows that in 2020, there was 2.26 million new cases of breast cancer worldwide, surpassing the 2.2 million cases of lung cancer. Breast cancer has replaced lung cancer and became the world's largest cancer. With the innovation of treatment concepts and the development of medical technology, breast-conserving surgery for early stage breast cancer can achieve the same curative effect as traditional surgery, with less trauma to patients, ideal aesthetic satisfaction, and improved quality of life for patients. However, there are also shortcomings, such as patients with small breasts, it is still difficult to achieve a satisfactory shape. With the advancement of imaging technology, cryoablation has been successfully used in patients with early-stage low-risk breast cancer. Japanese expert Fukuma has carried out such research. The results show that the local recurrence rate of patients is low, the medium and long-term survival effect is definite, and good cosmetic results can be achieved.

The Co-Ablation System that integrates the cryoablation and hyperthermia technology in this study can reduce the temperature of cryoablation to the ultra-low temperature level of -196 ℃ and the temperature of thermal ablation to the ultra-high temperature level of 80 ℃ by using low-temperature treatment technology. The clinical applications have proved that it can has a killing effect to tumor tissues. The ablation device of this technology has been approved by the National Medical Products Administration (registration number: National Instruments Note 20173583088 / 20173583089).

Study Design

This trial is a non-randomized parallel controlled clinical study to evaluate the efficacy and safety of Co-Ablation System ablation (experimental group) and breast-conserving surgery (control group) in the treatment of patients with early stage low-risk breast cancer. A new local ablation treatment method is provided.

This study plans to recruit 30 subjects with early stage breast cancer, all subjects will choose the group voluntarily and be treated according to the prescribed protocol. During the trial, subjects will undergo regular inspections and evaluations related to efficacy and safety.

Inclusion criteria (please read carefully before registering)

1. The patient is over 18 years old (subject to the date of signing the informed consent form);

2. Early stage low-risk breast cancer: single lesion, diameter <1.5cm, invasive breast cancer of DCIS or LuminalA type;

3. No lymph node metastasis;

4. Ultrasound visible lesions;

5. ECOG-PS score ≤ 2 or KPS score ≥ 70;

6. Voluntarily signed the informed consent and had good compliance during the study.

(Note: The above are the basic inclusion conditions, and the final selection will be determined by your research doctor.)

Exclusion criteria

1. Patients with chest trauma that may cause surgical infection;

2. Patients with severe infections and severe heart and brain diseases;

3. Human immunodeficiency virus (HIV) infection, active hepatitis B (antigen-positive hepatitis B and HBVDNA ≥ 500IU/ml), active hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the analytical method) detection limit);

4. Patients with lesions close to chest muscles, nipples or large blood vessels;

5. The patient is pregnant or breastfeeding;

6. Patients with other cancers;

7. The ipsilateral breast lump has received surgery or other invasive treatment within 3 months;

8. Severe coagulation disorders that cannot be corrected;

9. Diabetic patients with poor blood sugar control;

10. Implantation of foreign bodies around the tumor, which is expected to affect patients undergoing ablation or surgery;

11. Patients with old scars, damages and ulcers in the skin of the treatment area;

12. Other circumstances that make the patient unsuitable for Co-Ablation System ablation;

13. Invasive lobular carcinoma, mucinous adenocarcinoma and extensive intraductal carcinoma;

14. There are clear metastatic lesions in the axillary lymph nodes or the whole body;

15. Breast cancer with BRCA1/2 mutation;

16. Patients who the investigator considers unsuitable to participate in this clinical study.

Rights

1. It is possible to enjoy a free Co-Ablation System treatment during the treatment period if eligible for inclusion. Hygea Medical Technology Co., Ltd. will provide a free sterile disposable cryoablation needles(registration certificate number: National Instruments Note 20173583089) for volunteers in the experimental group ( for ablation surgery.

2. Volunteers who participate in the clinical trial throughout the whole process will be given a certain research fee after the trial, and can make an appointment for the outpatient clinic first.

Treatment and follow-up time

Focus on evaluating the local tumor recurrence rate 12 months after treatment in the two groups, patients' satisfaction with breast appearance within 1 week to 1 year after operation, 1-year/2-year/3-year/5-year disease progression-free survival rate after operation, and 5-year overall survival rate and maximum ice ball coverage and safety (adverse event rate) with Co-Ablation System ablation.

Consulting contact information

Project leader: Zhao Jin

Contact: 010-84205208/18518328086

Contact time: Monday to Friday 9:00-17:00

Clinic hours: Tuesday morning 8:30-12:00 Room 205, Outpatient Clinic, Second Floor, International Medical Department, China-Japan Friendship Hospital

Monday and Wednesday morning, 8:00-12:00, Clinic Room 11, General Surgery Clinic, China-Japan Friendship Hospital