Status:
UNKNOWN
Anlotinib to Malignant Brainstem Glioma
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Malignant Brain Stem Tumor
Glioma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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);
- 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;
- adequate renal function, defined as creatinine clearance ≥ 45 ml / min (Cockcroft-Gault formula);
- 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;
- 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;
- 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
- 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;
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04668508
Start Date
November 24 2020
End Date
January 1 2023
Last Update
December 16 2020
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022