A Phase II Study of Anlotinib Combined With Radiation in Patients With Malignant Brainstem Glioma
Overview
- Phase
- Phase 2
- Intervention
- Anlotinib
- Conditions
- Malignant Brain Stem Tumor
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- 6-month quality of life deterioration-free survival
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign written informed consent before any trial-related processes are implemented;
- •Age ≥ 18 years old and ≤ 70 years old;
- •Life expectancy exceeds 3 months;
- •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;
- •Patients with WHO Ⅲ - Ⅳ brain stem glioma confirmed by histology or radiology;
- •The Karnofsky score has to \>40;
- •For subjects who had undergone surgical biopsy or treatment, the surgical incision has to be healed well;
- •No prior radiotherapy, chemotherapy, immunotherapy or biotherapy has been performed;
- •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);
Exclusion Criteria
- •WHO grade I-II glioma or imaging diagnosis of low-level brainstem glioma;
- •Supratentorial gliomas in adults involve the brain stem;
- •Patients with contraindications for MRI;
- •Patients with any signs or history of bleeding physique;
- •Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose;
- •Severe intracranial infection;
- •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);
- •Prior or concurrent malignancies excepting for adequately treated skin cancer (non-melanoma), in situ cervical carcinoma or cured malignant disease≥5 years;
Arms & Interventions
anlotinib combined with radiation
Intervention: Anlotinib
Outcomes
Primary Outcomes
6-month quality of life deterioration-free 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
quality of life
disease control rate
Time Frame: through study completion, an average of 1 year
based on RECIST1.1
6-month progression-free survival rate
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
proportion of patients with progression-free survival longer than 6 months.
Secondary Outcomes
- 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)