跳至主要内容
临床试验/NCT05990556
NCT05990556招募中不适用

Research on the Safety and Efficacy of Blocking Dural Blood Supply in Glioblastoma Patients

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Patient survival period

研究概览

简要总结

Glioblastoma is the most common primary malignancy of the central nervous system with a very poor prognosis. Most of the immunotherapies that have made significant breakthroughs in the treatment of other tumors in recent years are unsatisfactory in the application of glioblastoma, which is mainly inseparable from the highly inhibitory immune microenvironment formed by the latter. Therefore, how to change this "immune desert" and better activate immune effector cells to play an anti-tumor effect is currently a hot spot in glioma immune research. In recent years, there has been continuous research support that the myeloid cells of the central nervous system are partly derived from the bone marrow of the skull, and there is a special channel connection between the skull and the dura mater, through which immune cells can be transported. This suggests that some of the tumor-associated macrophages recruited in the glioblastoma microenvironment may be passed through the dura mater. In previous animal experiments, we blocked the main blood supply to the dura mater by ligating the bilateral external carotid arteries of mice, cutting off the potential supply of dura mater to suppressor myeloid cells in the lesion. The results showed that after ligation of bilateral external carotid arteries, the survival period of tumor-forming mice was significantly prolonged and the prognosis was improved. The proportion of myeloid cells in the tumor microenvironment of mice decreased significantly, and the expression of tumor suppressor molecules such as arginase Arg1 decreased, indicating that the improvement of mouse prognosis was closely related to the proportion and phenotypic changes of myeloid cells after dural blood supply blockade. The meningeal lymphatic system of the human central nervous system has been shown to be an important part of the immune system, while the external carotid artery system, the main source of blood supply to the dura, carries abundant immune cells that ooze out to the dura mater through the endothelial window hole of the dural blood vessel, which is an important source of dural immune cells. In the glioblastoma immune microenvironment, the source of immune cells includes dural branches from the external carotid artery system in addition to branches of the internal carotid artery system. Therefore, for patients diagnosed with glioblastoma, this study involves embolization of the dural branch of the external carotid artery system (bilateral middle meningeal artery) to block the dural blood supply before craniotomy. At the same time, microsurgery under multimodal image navigation was used to remove the tumor. It is expected to be effective in reducing the proportion of myeloid suppressor cells in the tumor microenvironment, slowing the growth rate of residual tumor cells, and prolonging the tumor-free progression and survival of 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

盲法说明

Blinding and unblinding This is a real-world study that intends to include three patients as case studies without blinding prior to intervention and therefore does not involve blinding.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Imaging or needle biopsy pathologically diagnosed as glioblastoma
  • Patients have not previously received radiotherapy, chemotherapy and other treatment modalities for intracranial lesions
  • There are no related contraindications such as neurovascular intervention and craniotomy

排除标准

  • The patient's initial imaging diagnosis was glioblastoma, and the postoperative pathology confirmed nonglioblastoma
  • The patient has other underlying medical conditions that affect survival time
  • The patient had other underlying medical conditions that affected follow-up or quality of life assessment
  • Patients do not have the above exclusion criteria and refuse to participate in clinical trials after informed consent

结局指标

主要结局

Patient survival period

时间窗: 15 months

The overall survival of enrolled patients was compared with the overall survival reported in the literature

次要结局

  • Postoperative recurring time(3-6 months)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Nu

Discipline Leader of Neurosurgery department, Clinical Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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