Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer
Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer
Ablative therapy, as a local treatment modality for tumors, has an immune activating effect.
 To explore the synergistic effect of microwave ablation combined with PD-1 inhibitors, this
 prospective, open-label, multi-cohort, single-center clinical study was conducted. To compare
 the feasibility and safety of preoperative microwave ablation alone, with or without
 camrelizumab in patients with early newly diagnosed breast cancer.
Inclusion Criteria:

 1. Female.

 2. Age 20-65 years.

 3. Invasive carcinoma confirmed by core biopsy.

 4. Newly diagnosed breast cancer patients, without adjuvant therapy.

 5. Imaging findings showed a single breast tumor with a maximum diameter of 3 cm, no
 distant metastasis, and no invasion of the skin and chest wall.

 6. Systematic ultrasound is able to visualize lesions.

 7. Surgical treatment was planned.

 8. The functional level of major organs must meet the following requirements:

 1. blood routine: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L;
 hemoglobin (Hb) ≥ 90 g/L;

 2. blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine
 aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline
 phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 ×
 ULN;

 3. coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5
 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

 4. Heart: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by
 echocardiography (ECHO) or multigated acquisition (MUGA).

 5. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4
 levels should be investigated, and normal T3 and T4 levels can be included.

 6. Urinalysis: urine protein < 2 +, if urine protein ≥ 2 +, 24-hour urine protein
 quantification must show protein ≤ 1 g.

 9. Voluntarily participate in this study, sign informed consent, have good compliance and
 are willing to cooperate with follow-up.

 Exclusion Criteria:

 1. Tumor involving skin, ulceration, inflammatory breast cancer patients

 2. Fatty breast cancer.

 3. Tumors on the deep surface of areolar region

 4. KPS score < 70, or ECOG score > 2

 5. Patients with a history of concomitant collagen connective tissue disease, or any
 active autoimmune disease or autoimmune disease.

 6. Prior radiotherapy or prior use of investigational drugs or other immunosuppressive
 agents

 7. Heart, brain, lung, kidney and other vital organ failure, liver and kidney
 dysfunction;

 8. Uncorrectable severe coagulopathy

 9. Patient is pregnant or lactating

 10. Poor glycemic control in diabetes

 11. Patients with foreign body implantation around the tumor

 12. Patients with severe scars on the skin of the treatment area (protruding from the skin
 surface, width ≥ 1 cm)

 13. History of chronic immunosuppression, prior immunotherapy, recent vaccination (< 4
 weeks)

 14. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B
 indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody
 positive and HCV-RNA above the lower limit of detection of the analytical method).

 15. Concurrent medical conditions that, in the judgment of the investigator, would
 jeopardize the subject's safety, could confound the study results, or affect the
 subject's completion of this study.