Anlotinib to Malignant Brainstem Glioma

This is an interventional treatment trial for Malignant Brain Stem Tumor Read More

Inclusion Criteria:

1. Sign written informed consent before any trial-related processes are implemented;
2. Age ≥ 18 years old and ≤ 70 years old;
3. Life expectancy exceeds 3 months;
4. The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if it is confirmed to have progressed;
5. Patients with WHO Ⅲ - Ⅳ brain stem glioma confirmed by histology or radiology;
6. The Karnofsky score has to >40;
7. For subjects who had undergone surgical biopsy or treatment, the surgical incision has to be healed well;
8. No prior radiotherapy, chemotherapy, immunotherapy or biotherapy has been performed;

9. Hematological function is sufficient, defined as absolute neutrophil count

   ≥1.5×109 /L, platelet count ≥100 ×109 /L, hemoglobin ≥90g/L (no history of blood transfusion within 7 days);

10. Hepatic function is adequate, defined as all patients with total bilirubin levels ≤ 1.5 times normal upper limit (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases , AST and ALT levels ≤ 5 times ULN;
11. adequate renal function, defined as creatinine clearance ≥ 45 ml / min (Cockcroft-Gault formula);
12. Coagulation function is adequate, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as the INR or PT is within the range of anticoagulant drugs can;
13. Female subjects of childbearing age should be negative for urine or serum pregnancy test within 3 days prior to receiving the first study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required;
14. If there is a risk of conception, male and female patients need to use high-efficiency contraception (ie, an annual failure rate of less than 1%) and continue until at least 180 days after stopping the trial treatment; Note: If abstinence is normal for the subject Lifestyle and preferred methods of contraception can be used as a method of contraception.

Exclusion Criteria:

1. WHO grade I-II glioma or imaging diagnosis of low-level brainstem glioma;
2. Supratentorial gliomas in adults involve the brain stem;
3. Patients with contraindications for MRI;
4. Patients with any signs or history of bleeding physique;
5. Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose;
6. Severe intracranial infection;
7. Any arterial thrombosis, embolism or ischemia occurred within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to enrollment (implanted IV port or catheter-derived thrombosis, or superficial vein thrombosis is not considered a "serious" thrombosis embolism);
8. Prior or concurrent malignancies excepting for adequately treated skin cancer (non-melanoma), in situ cervical carcinoma or cured malignant disease≥5 years;