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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
concurrent using anlotinib combined with radiation plus adjuvant anlotinib after radiotherapy until disease progress or develop into serious adverse events.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGdisease control rate
based on RECIST1.1
Time frame: through study completion, an average of 1 year
6-month progression-free survival rate
proportion of patients with progression-free survival longer than 6 months.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
6-month quality of life deterioration-free survival
quality of life
Time frame: 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
overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 6 months
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