NCT04805736已完成2 期
A Pilot Study of Single-Dose Camrelizumab and/or Microwave Ablation in Women With Early-Stage Breast Cancer
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety of Microwave Ablation Combined With Camrelizumab
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Microwave Ablation alone
Experimental
Microwave Ablation+ Breast Surgery
干预措施: Microwave Ablation (Procedure)
Microwave Ablation alone
Experimental
Microwave Ablation+ Breast Surgery
干预措施: Breast Surgery (Procedure)
Camrelizumab alone
Experimental
Camrelizumab+ Breast Surgery
干预措施: Camrelizumab (Drug)
Camrelizumab alone
Experimental
Camrelizumab+ Breast Surgery
干预措施: Breast Surgery (Procedure)
Microwave Ablation & Camrelizumab
Experimental
Microwave Ablation + Camrelizumab + Breast Surgery
干预措施: Microwave Ablation (Procedure)
Microwave Ablation & Camrelizumab
Experimental
Microwave Ablation + Camrelizumab + Breast Surgery
干预措施: Camrelizumab (Drug)
Microwave Ablation & Camrelizumab
Experimental
Microwave Ablation + Camrelizumab + Breast Surgery
干预措施: Breast Surgery (Procedure)
结局指标
主要结局
Safety of Microwave Ablation Combined With Camrelizumab
时间窗: 3 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
次要结局
- Breast self evaluation(3 months)
- Complete ablation rate(1 day)
- Negative predictive value of ultrasound(1 day)
- Assessment of Immunogenicity(3 months)
研究者
Shui Wang
Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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