Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327451
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-20
Brief Title:
Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
Sponsor:
Tianjin Medical University General Hospital
Organization:
Tianjin Medical University General Hospital
Study Overview
Official Title:
Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glioblastoma GBM is the primary intracranial malignant tumor with the highest morbidity and mortality and the 5-year survival rate is less than 10 The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year which seriously threatens peoples life and health At present the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory and the median survival time of GBM patients is only 144 months Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia In recent years statins have shown good anti-tumor effect Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway Therefore the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin ATO combined with temozolomide TMZ in primary and recurrent glioblastomas with high EGFR expression
The investigators designed a multicenter single-arm double-blind phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM After informed consent was signed by the patient or authorized family members the patients were treated with the current STUPP regimen and ATO 20mg qn orally The patients were regularly followed up for 52 weeks after treatment The primary endpoint was progression-free survival PFS which was defined as the time from the start of GBM surgery to tumor progression recurrence or death The secondary end point was the rate of tumor control which was defined as the proportion of patients with a complete response a partial response or a stable disease that had shrunk or remained stable for a given period of time Safety will be assessed during the study by monitoring of regular MRI scans laboratory tests liver function lipid profile blood routine electrocardiography vital signs blood pressure pulse temperature and weight
The results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety
The investigators designed a multicenter single-arm double-blind phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM After informed consent was signed by the patient or authorized family members the patients were treated with the current STUPP regimen and ATO 20mg qn orally The patients were regularly followed up for 52 weeks after treatment The primary endpoint was progression-free survival PFS which was defined as the time from the start of GBM surgery to tumor progression recurrence or death The secondary end point was the rate of tumor control which was defined as the proportion of patients with a complete response a partial response or a stable disease that had shrunk or remained stable for a given period of time Safety will be assessed during the study by monitoring of regular MRI scans laboratory tests liver function lipid profile blood routine electrocardiography vital signs blood pressure pulse temperature and weight
The results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None