A Clinical Study of Albumin-bound Paclitaxel/granulocyte-based Therapy for Recurrent/metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To verity the safety of Albumin-bound Paclitaxel/Granulocyte in the treatment of Recurrent/Metastatic Breast Cancer
研究概览
简要总结
The goal of this clinical trial is to learn if Albumin-bound Paclitaxel/Granulocyte drug can treat patients with recurrent/metastatic breast cancer. The main questions it aims to answer are:
To verify the safety of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.
To evaluate the efficacy of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.
To detect the pharmacokinetic behavior of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.
详细描述
In this open, single-armed study, selected patients with recurrent/metastatic breast cancer confirmed by Histopathology will be received Albumin-bound Paclitaxel/Granulocyte-based therapy. The granulocyte will be separated by blood cell separator, and will be cultured in the GMP laboratory to make Albumin-bound Paclitaxel/Granulocyte drug. Then the drug will be infused intravenous into patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged ≥ 18 years old; Obtain an informed consent form voluntarily signed by the patient themselves; Recurrent/metastatic advanced breast cancer patients (refer to TNM standard); Patients who have received standard first-line treatments and expected survival time ≥ 3 months; EOCG score ≤ 2 and KPS≥ 70 points; Liver, kidney and bone marrow functions are basically normal; Patients of childbearing age need to take appropriate protective measures before enrollment and after treatment 3 months.
排除标准
- •Individuals who have received other anti-tumor treatment within 4 weeks prior the enrollment; Patients with history of allergy to paclitaxel, albumin naproxen, ibuprofen, trimethoprim and ampicillin; Positive blood pregnancy test; Patients who required anti coagulant therapy; Patients with active infectious diseases or a history of bone marrow or organ transplantation
研究组 & 干预措施
Albumin paclitaxel/neutrophil drug
Isolate the patients' autologous neutriphil cells, induce and culture them with albumin paclitaxel in vitro. Then the drug will be infused intravenously into patients. The number of neutriphil cells will be more than 1.0E10.
干预措施: Albumin paclitaxel/neutrophil drug (Biological)
结局指标
主要结局
To verity the safety of Albumin-bound Paclitaxel/Granulocyte in the treatment of Recurrent/Metastatic Breast Cancer
时间窗: 13 months
The adverse events and severe adverse events will be evaluated.
次要结局
- To evaluate the efficiency of Albumin-bound Paclitaxel/Granulocyte drug in the treatment of Recurrent/Metastatic Breast Cancer(13 months)
研究者
JIANG LONGWEI
associate researcher
Jinling Hospital, China