💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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