Glioma, Malignant Brain Stem Tumor
Conditions
Brief summary
This study is a single-arm, open-label, phase II study of anlotinib combined with radiation in the treatment of patients with malignant brainstem glioma. Twenty five patients will be enrolled in the study who is diagonsis with malignant brainstem glioma. The primary objective includes disease control rate (DCR), the role of antinib combined with radiotherapy in improving quality of life and 6-month progression-free survival rate. The secondary objective include overall survival (OS), toxicity profile. Exploratory objectives include the use of plasma specimens and cerebrospinal fluid (if possible) to detect biomarkers predicting the efficacy of anlotinib.
Interventions
DRUGAnlotinib
concurrent using anlotinib combined with radiation plus adjuvant anlotinib after radiotherapy until disease progress or develop into serious adverse events.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Anlotinib combined with radiation
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate | through study completion, an average of 1 year | based on RECIST1.1 |
| 6-month progression-free survival rate | From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months | proportion of patients with progression-free survival longer than 6 months. |
| 6-month quality of life deterioration-free survival | From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months | quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months | overall survival |
Countries
China
Contacts
Primary ContactYuanyuan Chen, Professor
Outcome results
None listed