A Prospective, Open-label, Single-center, Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Assessment of immune activating response
研究概览
简要总结
In this study, breast cancer (BC) patients eligible for inclusion will be divided into two groups according to molecular typing and subtyping, which combined immunotherapy and multimodal thermal therapy with conventional neoadjuvant chemotherapy, to explore methods of immune induction for BC, enhance the efficacy of immunotherapy, and accumulate data for subsequent stages of clinical study.
详细描述
Local tumor destruction with non-surgical ablation (NSA, cryoablation or radiofrequency) induces inflammation and releases antigens that can activate tumor-specific immune responses.
Pre-clinically, we demonstrated that multimodal thermal therapy (MTT) as an integrated treatment modality of cryotherapy and radiofrequency heating, can effectively activate systemic and long-lasting antitumor immunity.
In this pilot study, patients with operable HER2-negative breast cancer were designed to receive a combination of MTT, immunotherapy and neoadjuvant chemotherapy. Potential favorable intra-tumoral and systemic immunologic effects were assessed with the combination, revealing the possibility for induced and synergistic anti-tumor immunity with this strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female，age 18-70 years.
- •Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria;
- •TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC);
- •At least one measurable lesion according to RECIST 1.1 criteria;
- •Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine < 1 x ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;
- •Ability to understand and willingness to sign a written informed consent.
排除标准
- •Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
- •Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);
- •Patients with severe systemic infections or other serious diseases;
- •Patients with known allergy or intolerance to the study drug or its excipients;
- •Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
- •Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;
- •Participated in other trial studies within 30 days before the administration of the first dose of the study drug;
- •Endocrine system disorders;
- •Patients who were judged by the investigator to be unsuitable for this study.
研究组 & 干预措施
Hormone Receptor-positive (HR+) and HER2-negative (HER2-)
干预措施: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin (Combination Product)
Triple-negative Breast Cancer with Non-immunomodulatory Subtype
干预措施: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin (Combination Product)
结局指标
主要结局
Assessment of immune activating response
时间窗: up to 28 weeks
* Proportion of subjects with immune response to combination therapy detected by biomarkers in peripheral blood samples * Evaluate the infiltration of immune cells in tumor areas and adjacent tissues
次要结局
- CTCAE scale (V4.0)(up to 28 weeks)