Glioblastoma
Conditions
Interventions
Atorvastatin administrating group:According to the clinical standard dose of lipid-lowering drugs, the included subjects took 1 tablet of Lipitor orally every night after 2 weeks of glioma surgery, on
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion 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 grade 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Tumor control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatic burden of atorvastatin in GBM patients;Safety of atorvastatin in combination with TMZ; | — |
Countries
China
Contacts
Public ContactChunsheng Kang
Tianjin Medical University General Hospital
Outcome results
None listed