high-grade glioma
Conditions
Interventions
High-grade glioma:Anlotinib
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with primary tumor must be pathologically diagnosed as high-grade glioma (WHO III and WHO IV); 2. The primary tumor progressed or relapsed after surgery (including biopsy, partial resection, total resection), standard radiotherapy and temozolomide concurrent chemotherapy and temozolomide adjuvant chemotherapy (STUPP regimen). The pseudo progression must be excluded before enrollment; 3. Aged 18 to 75 years old; 4. The expected survival time is no less than 12 weeks; 5. There was at least one measurable or evaluable lesion according to the RANO criteria; 6. KPS >= 60; 7. Having adequate organ and bone marrow function, defined as follows: (1) Blood routine examination: white blood cell >= 3.5 x 10^9/L absolute neutrophil count >= 1.5 x 10^9/L; platelet count >= 100 x 10^9/L; hemoglobin content >= 9.0 g/dl; (2) Liver function: serum total bilirubin (TBIL) = 50ml/min; urine test results showed that urinary protein < 2 +; (4) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 UL; 8. The patient must have fully recovered from the toxicity of previous chemotherapy or targeted therapy, and at least 14 days from the last treatment; 9. Patients of childbearing age (including female and male patients' female partners) must take effective birth control measures; 10. The patient voluntarily joined the study and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have used antiangiogenic drugs and targeted therapies in the past (including, bevacizumab, apatinib and so on); 2. MRI suggests the recent risk of cerebral hemorrhage or brain herniation; 3. Patients whose imaging shows that the tumor has invaded important blood vessels or the researcher judges that the tumor is likely to invade important blood vessels causing fatal hemorrhage during the follow-up study; 4. Patients with any bleeding or bleeding event >= CTCAE level 3, unhealed wounds, ulcers or fractures, within 4 weeks before enrollment; 5. Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg); 6. Patients with myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QTC >= 480ms), and grade >= 2 congestive heart failure (New York Heart Association (NYHA) classification); 7. Active or uncontrolled serious infection; 8. Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 9. Renal failure requires hemodialysis or peritoneal dialysis; 10. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 11. Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L); 12. Urine routines suggest that urine protein is >= ++, and the 24-hour urine protein quantification is more than 1.0 g; 13. Those considered by the researcher to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Progress free survival (PFS);Overall survival (OS);Adverse effect (AE); | — |
Countries
China
Contacts
Public ContactWang Chaojie
Henan Provincial People's Hospital
Outcome results
None listed