Glioblastoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old; 2. Karnofsky Functional State Score (KPS) >=60; 3. Histopathological diagnosis of primary/recurrent glioblastoma; 4. Have a measurable or evaluable lesion confirmed by MRI with a life expectancy of at least 12 weeks, and agree to undergo surgical resection of the lesion; 5. Have sufficient bone marrow function, be able to receive follow-up adjuvant therapy (white blood cell count>=4000/µL, neutrophil count>=1500/µL, platelet count>=100,000/µL, hemoglobin>=8.0g/dL), renal function (serum creatinine<=150µmol/L, 24-hour urine protein<=3.4g) and liver function (total bilirubin<=34µmol/L, aspartate and alanine aminotransferase<=120U/L). 6. Subjects voluntarily participate in this clinical study, fully understand the research purpose, research steps and research content, are willing to follow and have the ability to complete all trial procedures and comply with the prohibitions and constraints specified in this research protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Extracranial metastatic disease; 2. Previous or ongoing Carmustine microchip implant (Gliadel) treatment; 3. Severe cardiopulmonary insufficiency; 4. Status epilepticus; 5. Pregnant or lactating women; 6. Gastrointestinal bleeding; 7. Uncontrolled blood pressure (>140/90mmHg) after taking the drug; 8. Frequent vomiting, dysphagia or other conditions that affect the oral administration of drugs; 9. HIV-positive and antiretroviral therapy; 10. Patients who are currently participating in other clinical trials, or who have participated in previous trials and have not terminated the trial; 11. Other conditions that the investigator considers unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival; | — |
Countries
China
Contacts
Nanfang Hospital, Southern Medical University