Status:
COMPLETED
Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-65 years
Phase:
PHASE2
Brief Summary
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, op...
Eligibility Criteria
Inclusion
- Female.
- Age 20-65 years.
- Invasive carcinoma confirmed by core biopsy.
- Newly diagnosed breast cancer patients, without adjuvant therapy.
- 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.
- Systematic ultrasound is able to visualize lesions.
- Surgical treatment was planned.
- The functional level of major organs must meet the following requirements:
- blood routine: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L;
- 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;
- coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Heart: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA).
- 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.
- Urinalysis: urine protein \< 2 +, if urine protein ≥ 2 +, 24-hour urine protein quantification must show protein ≤ 1 g.
- Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion
- Tumor involving skin, ulceration, inflammatory breast cancer patients
- Fatty breast cancer.
- Tumors on the deep surface of areolar region
- KPS score \< 70, or ECOG score \> 2
- Patients with a history of concomitant collagen connective tissue disease, or any active autoimmune disease or autoimmune disease.
- Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents
- Heart, brain, lung, kidney and other vital organ failure, liver and kidney dysfunction;
- Uncorrectable severe coagulopathy
- Patient is pregnant or lactating
- Poor glycemic control in diabetes
- Patients with foreign body implantation around the tumor
- Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
- History of chronic immunosuppression, prior immunotherapy, recent vaccination (\< 4 weeks)
- 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).
- 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.
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04805736
Start Date
March 25 2021
End Date
April 30 2023
Last Update
January 5 2024
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China