GlioblastomaNCT05990556
Research on the Safety and Efficacy of Blocking Dural Blood Supply in Glioblastoma Patients
A study testing interventional procedure to block bilateral meningeal blood supply in people with Glioblastoma and Meningeal Arteries, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma, Meningeal Arteries
- What is being tested?
- interventional procedure to block bilateral meningeal blood supply
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Nu Zhang, Professor, 13825070717, zhangnu2@mail.sysu.edu.cn
About this study
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.
- Conditions
- Glioblastoma, Meningeal Arteries
- Being tested
- interventional procedure to block bilateral meningeal blood supply
- Keywords
- glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventional procedure to block bilateral meningeal blood supplyProcedure or surgery
The embolic agent used in bilateral meningeal blood supply occlusion through interventional surgery is Onyx glue ("liquid embolic system"). After the location of bilateral middle meningeal artery was determined by femoral artery puncture angiography, SL-10 was sent to the opening of bilateral middle meningeal artery through guiding catheter, and Onxy glue was used to block the bilateral middle meningeal artery. The standard of embolization was that the middle meningeal artery was not seen and Onyx glue was not diffused to the petrous branch of the middle meningeal artery. In order to avoid dangerous anastomotic branches and complications, attention should be paid to superselecting the middle meningeal artery and slowly injecting Onyx glue during the operation. After embolization of the middle meningeal artery by interventional surgery, glioblastoma was removed immediately under the guidance of multimodal imaging.
| Study group | Role | What they receive |
|---|---|---|
| interventional procedure to block bilateral meningeal blood supply | Experimental | Not described Receives: Procedure: interventional procedure to block bilateral meningeal blood supply |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival period
The overall survival of enrolled patients was compared with the overall survival reported in the literature
Measured: 15 months
Secondary outcomes (1)
Postoperative recurring time
The Postoperative recurring time in enrolled patients was compared with the mean time in the literature
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start11 May 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional single-arm studies, no grouping. 1 Randomize groupings 1.1 Method for generating random sequence assignments This study is a real-world study, it is planned to include 20 patients as a case, there is no need for random sequence and blinded allocation before intervention, the patient's condition, experimental purpose, experimental method and possible risks are informed before surgery, and the patient chooses whether to undergo preoperative interventional surgery to block bilateral meningeal blood supply. 1.2 Randomly assigned hiding This is a real-world study that intends to include three patients as individual cases without random sequencing prior to intervention and therefore does not involve allocation concealment.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Nu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Nu Zhang, Professor, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990556
- Sponsor's protocol ID
- ZNu
- Status last verified
- Jul 2024
- First submitted
- 7 Aug 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Safety and Efficacy of Blocking Dural Blood Supply in Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT05990556
- Acronym / sponsor ID
- ZNu
- Conditions
- Glioblastoma, Meningeal Arteries
- Keywords
- glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 11 May 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional single-arm studies, no grouping. 1 Randomize groupings 1.1 Method for generating random sequence assignments This study is a real-world study, it is planned to include 20 patients as a case, there is no need for random sequence and blinded allocation before intervention, the patient's condition, experimental purpose, experimental method and possible risks are informed before surgery, and the patient chooses whether to undergo preoperative interventional surgery to block bilateral meningeal blood supply. 1.2 Randomly assigned hiding This is a real-world study that intends to include three patients as individual cases without random sequencing prior to intervention and therefore does not involve allocation concealment.
| Arm | Type | Receives |
|---|---|---|
| interventional procedure to block bilateral meningeal blood supply | Experimental | Procedure: interventional procedure to block bilateral meningeal blood supply |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interventional procedure to block bilateral meningeal blood supplyThe embolic agent used in bilateral meningeal blood supply occlusion through interventional surgery is Onyx glue ("liquid embolic system"). After the location of bilateral middle meningeal artery was determined by femoral artery puncture angiography, SL-10 was sent to the opening of bilateral middle meningeal artery through guiding catheter, and Onxy glue was used to block the bilateral middle meningeal artery. The standard of embolization was that the middle meningeal artery was not seen and Onyx glue was not diffused to the petrous branch of the middle meningeal artery. In order to avoid dangerous anastomotic branches and complications, attention should be paid to superselecting the middle meningeal artery and slowly injecting Onyx glue during the operation. After embolization of the middle meningeal artery by interventional surgery, glioblastoma was removed immediately under the guidance of multimodal imaging. | Procedure or surgery | interventional procedure to block bilateral meningeal blood supply |
Primary outcome
Patient survival period
Time frame: 15 months
The overall survival of enrolled patients was compared with the overall survival reported in the literature
1 secondary outcome
Postoperative recurring time
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nu Zhang, Professor principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interventional procedure to block bilateral meningeal blood supply in people with Glioblastoma and Meningeal Arteries, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nu Zhang, Professor (13825070717, zhangnu2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival period (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.