A Study of Anlotinib in the Treatment of Recurrent High-grade Glioma

• Status: Recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of anlotinib in treatment of recurrent high-grade glioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First People's Hospital of Hangzhou
• Collaborator: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Criteria

Inclusion Criteria:

1. Age ≥18 years old (calculated on the day of signing the informed consent), regardless of gender.

2. Karnofsky score (KPS score) ≥60.

3. According to Rano criteria, there are evaluable intracranial lesions, and recurrent high-grade gliomas have been confirmed.

4. Patients have undergone surgery and relapsed after receiving standard radiotherapy and chemotherapy;

5. The toxicity has returned to ≤1 grade If have received chemotherapy;

6. Expected survival ≥ 3 months;

7. The patient has no major organ dysfunction. Specific laboratory indicators are required: white blood cells ≥3.0×109/L, platelets ≥75×109/L, hemoglobin ≥10g/dl, and serum bilirubin not greater than 1.5 times the maximum normal value; ALT and AST are not more than 2 times the maximum normal value; blood creatinine ≤ 1.5 mg/dl.

8. Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period.

9. The patient voluntarily joined the study and signed a written informed consent.

Exclusion Criteria:

1. Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);

2. Patients with any severe and/or uncontrollable disease, including:

1) Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); 2) 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); 3) Active or uncontrolled serious infection (≥CTC AE Grade 2 infection); 4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 7) Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L); 8) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein quantification is more than 1.0 g; 9) Patients who have seizures and need treatment; 3. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment; 4. 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; 5. Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event ≥ CTCAE level 3, unhealed wounds, ulcers or fractures; 6. Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 7. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 8. Participated in clinical research of other anti-tumor drugs within four weeks; 9. Have received the treatment of small molecule anti-angiogenesis targeted drugs (such as regorafenib, perzopanib, apatinib, etc.); 10. Those considered by the researcher to be unsuitable for inclusion。