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Tests treatment safety and results for Glioblastoma, IDH-wildtype
Official title Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma
ClinicalTrials.gov ID: NCT06327451
What this study is testing
What is Atorvastatin 20mg?
Atorvastatin 20mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma, idh-wildtype.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- age ≥18 years old and \< 60 years old, both sexes;
- sufficient evidence of glioma by MRI scan;
- According to the 2021 WHO latest classification, the molecular pathology of postoperative glioma samples was diagnosed as WHO 4 glioblastoma;
- The immunohistochemical results of postoperative glioma samples showed that EGFR score was 3 (standard: 0 was negative, 1-3 was positive);
- normal blood routine and liver function;
You likely can't join if
- allergy to atorvastatin or its components;
- concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral...
- other tumors (except glioma), hematological diseases or other known multiple organ failure, history of myasthenia gravis, heart failure, cerebral...
- History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin, hepatic and renal insufficiency, obesity, uncontrolled diabetes...
- abnormal liver function or liver disease, including uncontrolled hepatitis;
- other diseases that might interfere with the study, as determined by 2 attending neurosurgeons;
See the full eligibility criteria
- age ≥18 years old and \< 60 years old, both sexes;
- sufficient evidence of glioma by MRI scan;
- According to the 2021 WHO latest classification, the molecular pathology of postoperative glioma samples was diagnosed as WHO 4 glioblastoma;
- The immunohistochemical results of postoperative glioma samples showed that EGFR score was 3 (standard: 0 was negative, 1-3 was positive);
- normal blood routine and liver function;
- fully understand the nature of the trial and sign the informed consent;
- be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
- no serious diseases or accidents requiring surgery;
- normal immune function.
- allergy to atorvastatin or its components;
- concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives;
- other tumors (except glioma), hematological diseases or other known multiple organ failure, history of myasthenia gravis, heart failure, cerebral hernia and other serious complications;
- History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin, hepatic and renal insufficiency, obesity, uncontrolled diabetes and other metabolic diseases;
- abnormal liver function or liver disease, including uncontrolled hepatitis;
- other diseases that might interfere with the study, as determined by 2 attending neurosurgeons;
- patients enrolled in a clinical trial within the past 4 weeks;
- pregnant or lactating patients;
- patients with poor compliance who could not complete the treatment;
- other conditions that made the patient ineligible for enrollment as determined by the study investigator;
- patients with a history of HIV and/or HBV/HCV or presence of HIV/HCV;
- patients with a history of tuberculosis or known existence of tuberculosis;
- patients with severe infection or signs/symptoms of infection within 2 weeks before the first dose of study drug;
- patients who received live attenuated vaccine within 4 weeks before the first dose of study drug;
- patients with previous solid organ transplantation or hematopoietic stem cell transplantation. Those who meet any of the above criteria will not be selected.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.