NCT04822805

A Study of Anlotinib in the Treatment of Recurrent High-grade Glioma

Anlotinib in the Treatment of Recurrent High-grade Glioma： an Open-label Single-arm, Phase 2 Trials

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of anlotinib in treatment of recurrent high-grade glioma.

Detailed description

Glioma is a common primary central nervous system malignant tumor that originates from glial cells. High grade glioma (HGG) refers to grade III and IV gliomas in the central nervous system tumor classification of the World Health Organization (WHO), accounting for approximately 67% of newly diagnosed cases. The maximum safety resection of the tumor followed by radiotherapy and chemotherapy is the HGG standard initial treatment strategy. However, glioma cells grow aggressively, and most patients will relapse after initial treatment. Recurrent high-grade glioma (r-HGG) is difficult to treat, lacking treatment standards and having a poor prognosis. There is no standard treatment plan for patients with recurrent high-grade cancer. Studies have shown that gliomas highly express a variety of pro-angiogenic factors and have a large number of abnormally proliferated blood vessels, VEGF especially playing an important role in the formation of GBM neovascularization. VEGF is almost not expressed in normal tissues, but it is highly expressed (about 96%) in malignant gliomas and surrounding tissues, especially VEGF-A is highly expressed in glioblastomas. Therefore, VEGF It can be used as an effective target for anti-angiogenesis treatment of malignant glioma. Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor that has significant inhibitory activity against angiogenesis related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor related kinases such as PDGFR /, C-Kit, Ret, etc. (e.g., Met, FGFR1/2/3). Based on the above theory , the purpose of this study was to explore the efficacy and safety of anlotinib in treatment of recurrent high-grade glioma.

Conditions

• Recurrent High-grade Glioma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride	Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient.

Timeline

• Start date: 2020-04-13
• Primary completion: 2022-10-30
• Completion: 2023-03-30
• First posted: 2021-03-30
• Last updated: 2021-03-30

Locations

1 site across 1 country: China