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Trial Title:
Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
NCT ID:
NCT06327451
Condition:
Glioblastoma, IDH-wildtype
Conditions: Official terms:
Glioblastoma
Atorvastatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atorvastatin 20mg
Description:
Liptor is a capsule in the form of 20 mg, once daily.
Arm group label:
Atorvastatin administrating group
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 people's 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
14.4 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. age ≥18 years old and < 60 years old, both sexes;
2. sufficient evidence of glioma by MRI scan;
3. According to the 2021 WHO latest classification, the molecular pathology of
postoperative glioma samples was diagnosed as WHO 4 glioblastoma;
4. The immunohistochemical results of postoperative glioma samples showed that EGFR
score was 3 (standard: 0 was negative, 1-3 was positive);
5. normal blood routine and liver function;
6. fully understand the nature of the trial and sign the informed consent;
7. be willing and able to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures;
8. no serious diseases or accidents requiring surgery;
9. normal immune function.
Exclusion Criteria:
1. allergy to atorvastatin or its components;
2. concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir,
cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives;
3. other tumors (except glioma), hematological diseases or other known multiple organ
failure, history of myasthenia gravis, heart failure, cerebral hernia and other
serious complications;
4. History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin,
hepatic and renal insufficiency, obesity, uncontrolled diabetes and other metabolic
diseases;
5. abnormal liver function or liver disease, including uncontrolled hepatitis;
6. other diseases that might interfere with the study, as determined by 2 attending
neurosurgeons;
7. patients enrolled in a clinical trial within the past 4 weeks;
8. pregnant or lactating patients;
9. patients with poor compliance who could not complete the treatment;
10. other conditions that made the patient ineligible for enrollment as determined by
the study investigator;
11. patients with a history of HIV and/or HBV/HCV or presence of HIV/HCV;
12. patients with a history of tuberculosis or known existence of tuberculosis;
13. patients with severe infection or signs/symptoms of infection within 2 weeks before
the first dose of study drug;
14. patients who received live attenuated vaccine within 4 weeks before the first dose
of study drug;
15. patients with previous solid organ transplantation or hematopoietic stem cell
transplantation.
Those who meet any of the above criteria will not be selected.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunsheng Kang
Phone:
+8602260817499
Email:
kang97061@tmu.edu.cn
Contact backup:
Last name:
Xiaoteng Cui
Phone:
+8602260817481
Email:
xiaotengcui@tmu.edu.cn
Start date:
April 1, 2024
Completion date:
February 28, 2027
Lead sponsor:
Agency:
Tianjin Medical University General Hospital
Agency class:
Other
Source:
Tianjin Medical University General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06327451