Investigation of the Clinical and Laboratory Efficacy of Autogemotherapy Based on Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 26
- 主要终点
- Сytotoxicity
研究概览
简要总结
The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with breast cancer.
This technology is intended for complex treatment of patients with breast cancer and is aimed at preventing the occurrence and treatment of secondary foci. The need for this technology is justified by the widespread occurrence of breast cancer among women, a decrease in the average age at onset of the disease and a young age, and the chemoresistantness of locally advanced forms of cancer.
详细描述
Currently, technologies are being developed to improve the clinical outcomes of patients with complex treatment of breast cancer. Many patients are immunosuppressed after surgical, radiation and chemotherapeutic treatment, which leads to dysfunction of T cells, resulting in tumor cells avoiding immune surveillance. Restoration of antitumor immunity during immunotherapy is one of the modern approaches in the treatment of breast cancer, which contributes to the formation of an effective specific immune response, the destruction of tumor cells while minimizing toxicity. Dendritic cells (DC) and the lymphocytes induced by them are one of the most effective methods for the destruction of residual cancer cells, which are the leading cause of relapse and metastasis.
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
- 28 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For the first time established morphologically confirmed diagnosis of breast cancer
- •patients with II A, II B, IIIA, III B stages of breast cancer;
- •Patients with progressive or primary IV stage of breast cancer with cytologically confirmed and accessible soft tissue metastases;
- •Patients with HER-2 / neu 3 + positive and patients with triple negative breast cancer of the I-II stage (biologically unfavorable forms of breast cancer more prone to recurrence and metastasis).
- •Absence of severe somatic pathology in which medical intervention (at the stage of obtaining biological material or the stage of immunotherapy) will only worsen the patient's condition,
- •The patient's desire.
排除标准
- •Pregnancy at any time,
- •Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status,
- •Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified,
- •Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components,
- •Refusal of the patient to participate in the study in oral or written form.
- •Patient involvement in any other clinical study (including those that the patient has not been informed by the direct oncologist who has been treated, but which has become known already after the beginning of any stage of the study).
结局指标
主要结局
Сytotoxicity
时间窗: 6 months
A study of the cytotoxic activity of peripheral blood mononuclear cells against tumor cells of the MCF-7 line. The result will be presented as the level of cytotoxicity (%) against the cells of the tumor line. The determination of cytotoxicity is carried out using a lactate dehydrogenase test (Promega). The level of the enzyme is proportional to the level of cytotoxicity.
次要结局
- Parameters of peripheral blood(6 months)
- Immune status indicators(6 months)
- The content of immunosuppressive populations(6 months)
- Interrogation of the patient using a visual analogue scale(6 months)
- Relapse-free period(36 months)