Glioblastoma
Conditions
Interventions
Test group:Sequential combination therapy of anlotinib induction therapy and STUPP regimen
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years old, gender not limited, voluntary participation in the trial and signing of informed consent form; 2. Diagnosed with glioblastoma through histopathology; 3. Patients with residual lesions after surgery; 4. Patients undergoing stereotactic biopsy surgery; 5. ECOG score: 0-1 points; 6. Expected to survive for at least 3 months; 7. The main organ function meets the following criteria within 7 days before treatment: (1) Hemoglobin (HB) >= 90 g/L; (2) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (3) Platelet count (PLT) >= 100 × 10^9/L. 8. Biochemical tests must meet the following standards: (1) Total bilirubin (TBIL) = 60ml/min; 9. Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= lower limit of normal (50%); 10. Participants voluntarily join this study and sign an informed consent form (ICF); 11. It is expected that those with good compliance will be able to follow up on the efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Merge with other pathological types of secondary primary tumors; 2. Previously received treatment with anti angiogenic drugs, including bevacizumab, sunitinib, sorafenib, anlotinib, apatinib, etc; 3. Previous use of temozolomide, etc; 4. Patients with a serious history of allergies or allergic constitution; 5. Pregnant or lactating women; 6. Patients who have participated in other clinical trials in the past and have not yet terminated the trials; 7. Accompanied by pleural effusion or ascites, causing respiratory syndrome (>= CTC AE grade 2 respiratory distress); 8. Previously received cranial radiation therapy; 9. Patients with any severe and/or uncontrolled illnesses, including: (1) Patients with poor blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg); (2) Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QTc >= 480ms), and grade >= 2 congestive heart failure (NYHA classification); (3) Active or uncontrolled severe infections (>= CTC AE level 2 infection); (4) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral therapy; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (7) Two consecutive urine routine tests indicate urinary protein >=++and confirm 24-hour urine protein quantification>1.0 g; (8) Suffering from mental illnesses, including epilepsy, dementia, severe depression, mania, etc. 10. Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to grouping (based on clinical evaluation); 11. Patients whose imaging shows that the tumor has invaded important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal bleeding during subsequent studies; 12. Patients with any signs or medical history of bleeding, regardless of the severity; Patients who have experienced any bleeding or bleeding events >= CTCAE grade 3 within the first 4 weeks of enrollment, with unhealed wounds, ulcers, or fractures; 13. Those who have experienced arterial/venous thrombosis events within the past 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism; 14. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 15. Subjects with swallowing difficulties or known drug absorption disorders; 16. Researchers believe that there are other situations that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYao Chengyun
Jiangsu Cancer Hospital
Outcome results
None listed