Actively Recruiting
Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
Led by Tianjin Medical University General Hospital · Updated on 2024-03-25
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Glioblastoma (GBM) is a severe brain tumor with high rates of illness and death, and a 5-year survival rate below 10%. In China, GBM leads in new diagnoses and deaths annually, posing a serious health risk. Current treatments combining surgery, chemotherapy, radiotherapy, and tumor treating fields (TTF) have limited success, with median survival around 14.4 months. Statins, commonly used to lower cholesterol, have shown potential anti-tumor effects, including blocking glioma progression via the EGFR pathway. This study aims to evaluate how well atorvastatin combined with temozolomide works in patients with GBM that highly expresses EGFR. This is a multicenter, single-arm, double-blind phase II trial where participants receive standard STUPP regimen treatment plus oral atorvastatin (20 mg once daily) starting two weeks after glioma surgery. The study lasts for 52 weeks, during which patients are regularly monitored. The main goal is to assess progression-free survival (time until tumor growth or death). Secondary goals include tumor control rate and overall survival. Safety assessments include MRI scans, blood tests for liver function and lipids, electrocardiograms, vital signs, and weight monitoring. Participants will be followed closely with scheduled visits and evaluations throughout the 52-week period. Researchers will measure tumor progression, survival, and tumor size changes to understand treatment effects. Safety will be monitored continuously through clinical and laboratory tests. Results from this trial will provide important information on whether combining atorvastatin with temozolomide can safely extend progression-free survival in patients with EGFR-high glioblastoma.
CONDITIONS
Brief Title
Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and under 60 years, any sex
- Confirmed glioma diagnosis by MRI scan
- Postoperative glioma samples diagnosed as WHO grade 4 glioblastoma per 2021 WHO classification
- EGFR score of 3 on immunohistochemical analysis of postoperative glioma samples
- Normal blood routine and liver function tests
- Understand the trial and sign informed consent
- Willing and able to comply with scheduled visits, treatments, and tests
- No serious diseases or accidents requiring surgery
- Normal immune function
You will not qualify if you...
- Allergy to atorvastatin or its components
- Use of specific drugs including clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives
- Presence of other tumors (except glioma), blood diseases, multiple organ failure, or serious complications like myasthenia gravis, heart failure, cerebral hernia
- History of cardiac insufficiency, arrhythmia, retinopathy, hepatic porphyrin, liver or kidney failure, obesity, uncontrolled diabetes, or metabolic diseases
- Abnormal liver function or liver disease including uncontrolled hepatitis
- Other diseases interfering with study as determined by neurosurgeons
- Participation in another clinical trial within last 4 weeks
- Pregnancy or lactation
- Poor compliance or inability to complete treatment
- Other ineligibility conditions determined by investigators
- History or presence of HIV, HBV, or HCV
- History or presence of tuberculosis
- Severe infection or symptoms within 2 weeks before first dose
- Receipt of live attenuated vaccine within 4 weeks before first dose
- Previous solid organ or hematopoietic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants take one tablet of atorvastatin 20 mg orally every night starting 2 weeks after glioma surgery, combined with the STUPP protocol treatment.
Visits at 1, 3, and 6 months for assessments
Trial Site Locations
Total: 1 location
1
Tianjin Medical University General Hospital
Tianjin, China, 300052
Actively Recruiting
Research Team
C
Chunsheng Kang
X
Xiaoteng Cui
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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