NCT04668508

Anlotinib to Malignant Brainstem Glioma

A Phase II Study of Anlotinib Combined With Radiation in Patients With Malignant Brainstem Glioma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Brain Stem Tumor
• Glioma

Interventions

Type	Name	Description
DRUG	Anlotinib	concurrent using anlotinib combined with radiation plus adjuvant anlotinib after radiotherapy until disease progress or develop into serious adverse events.

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-06-30
• Completion: 2023-01-01
• First posted: 2020-12-16
• Last updated: 2020-12-16

Locations

1 site across 1 country: China