Glioma
Conditions
Interventions
Glioma group:Anlotinib hydrochloride,12mg, PO, QD, d1-14,Q3W
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Molecular pathological diagnosis of high-grade glioma (2016 WHO grade III or IV); 2. Aged 18 - 75 years, KPS score >= 60, and the expected survival period is more than 3 months; 3. After first-line or above standard treatment failure; 4. Imaging confirmed recurrence (according to RANO criteria); 5. The time of the first medication after enrollment should be more than 4 weeks away from the surgery or the last radiotherapy; 6. Confirmed progression time is >= 4 weeks from the last drug treatment (including adjuvant TMZ chemotherapy after the completion of concurrent chemoradiotherapy); 7. Have not received anti-angiogenesis drug treatment before; 8. If the patient is on hormone therapy, the hormone dose must be stable or reduced for at least 7 days before the baseline MRI examination; 9. Major organ function within 7 days prior to treatment, meeting the following criteria: (1) Routine blood test standards (without blood transfusion within 14 days): 1) Hemoglobin (HB) >= 90 g/L; 2) Absolute neutrophil count (ANC) >= 1.5×10^9/L; 3) Platelet (PLT) >= 90×10^9/L; (2) The biochemical examination shall meet the following standards: 4) Total bilirubin (TBIL) = 60 ml/min; (3) Echocardiography: Left ventricular ejection fraction (LVEF) >= lower limit of normal (50%); (4) International normalized ratio (INR), partial thromboplastin time (APTT), prothrombin time (PT) <= 1.5 ULN; 10. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 7 days before study enrollment, and Must be a non-lactating patient; men should agree to use contraception during the study period and within 6 months after the end of the study period; 11. Patients voluntarily joined the study and signed informed consen.
Exclusion criteria
Exclusion criteria: 1. Anlotinib hydrochloride has been used in the past; 2. Plan to perform other systemic anti-tumor therapy or external radiation or other interventional therapy during the study medication period; 3. Patients who have had or are currently suffering from other malignant tumors or solid organ or bone marrow transplantation within 5 years. Excludes cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors; 4. Baseline MRI suggests a recent risk of intracerebral hemorrhage or herniation; 5. Unresolved toxicities with an AE (5.0) greater than or equal to grade 2 due to any previous treatment, excluding alopecia. 6. Those who are unable to take orally or swallow drugs; 7. With pleural effusion or ascites, causing respiratory syndrome (>= CTC AE grade 2 dyspnea); 8. Patients with any severe and/or uncontrolled disease, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg) using one antihypertensive drug; patients with previous hypertensive encephalopathy (2) Significant cardiovascular damage includes but is not limited to: >= grade II cardiac insufficiency (New York Heart Association (NYHA) classification), unstable angina, myocardial infarction, ischemic cardiomyopathy or 6 months before the first dose stroke (3) Grade 1 or higher sinus bradycardia (CTCAE 5.0); or second degree or higher atrioventricular block, or sinus arrest (except for those with a pacemaker installed); arrhythmia (including QTC >= 470 ms); Concomitant use of drugs known to prolong the QTc interval, including antiarrhythmic therapy; (4) Intracranial abscess has occurred within 6 months; (5) Active or uncontrolled serious infection (>= CTC AE grade 2 infection); (6) Patients with liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; (7) Renal failure requires hemodialysis or peritoneal dialysis; (8) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (9) Poor blood sugar control in diabetic patients (fasting blood glucose (FBG) > 10 mmol/L); (10) Urine routine indicates urine protein >= ++, and confirmed 24-hour urine protein quantification > 1.0 g; 9. Received major surgical treatment, incisional biopsy or obvious traumatic injury within 28 days before enrollment; 10. Regardless of the severity, patients with any signs of the bleeding constitution or medical history; patients with any bleeding or bleeding events = CTCAE grade 2 within 4 weeks before enrollment, with unhealed wounds, ulcers or fractures 11. Those who have experienced arterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 12. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 13. Those who have participated in clinical trials of other anti-tumor drugs or are undergoing other clinical trials within four weeks; 14. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Progression-Free-Survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) ;Objective response rate (ORR) ;Overall survival (OS) ;Disease Control Rate (DCR) ;Glucocorticoid use;Quality of life (EORTC QLQ-C30 score); | — |
Countries
China
Contacts
Public ContactQu Xiujuan
The First Affiliated Hospital of China Medical University
Outcome results
None listed