Glioblastoma Multiforme
Conditions
Interventions
Silibilin administrating group :According to the clinical standard dose, the included subjects took 4 capsules of silibilin orally postprandial after 4 weeks of glioma surgery, on the basis of other t
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
14 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age >=14 years and <60 years, with no gender restrictions; 2.Adequate evidence of glioma through MRI scans; 3.Molecular pathological diagnosis classified as WHO Grade 4 Glioblastoma according to the latest 2021 WHO classification; 4.Normal blood routine and liver function; 5.Fully understand the nature of this trial and have signed the informed consent form; 6.Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other research procedures; 7.No major diseases or emergencies requiring urgent surgery; 8.Normal immune function.
Exclusion criteria
Exclusion criteria: 1. Allergic to silibilin ; 2. Concurrent use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives, etc.; 3. Other tumors (except glioma), hematological diseases, or known multi-organ failure, history of myasthenia gravis, heart failure, brain herniation, and other serious comorbidities; 4. History of heart failure, arrhythmias, retinopathy, acute porphyria, liver and kidney insufficiency, obesity, uncontrolled diabetes, and other metabolic diseases; 5. Abnormal liver function or liver disease, including uncontrolled hepatitis; 6. Other diseases that may interfere with the study, determined by two attending neurosurgeons; 7. Patients who have participated in clinical trials within the past 4 weeks; 8. Pregnant or breastfeeding patients; 9. Patients with poor compliance who cannot complete the treatment; 10. Other conditions determined by the study investigators that make the patient unsuitable for enrollment; 11. History of HIV and/or HBV/HCV or patients with HIV/HCV; 12. History of tuberculosis or patients known to have tuberculosis; 13. Patients with severe infection or signs/symptoms of infection within 2 weeks before the first administration of the study drug; 14. Patients who have received live attenuated vaccines within 4 weeks before the first administration of the study drug; 15. Patients who have previously undergone solid organ transplantation or hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ;Overall survival ;Safety of silibilin in combination with TMZ ; | — |
Countries
China
Contacts
Public ContactGe Pengfei
The First Hospital of Jilin University
Outcome results
None listed