Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06327451
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06327451
Study Brief:
Protocol Section:
NCT06327451