NCT04253873

Clinical Study of Apatinib Combined With Temozolomide in the Treatment of Uncontrolled or Repeated High-grade Gliomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: WuHui · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Gliomas are the most common malignant tumors of the central nervous system and are highly invasive. Gliomas account for one-third of central nervous system tumors in adults and children. Interstitial astrocytomas and glioblastomas are also called high-grade gliomas, accounting for 77.5% of all gliomas.

Detailed description

Temozolomide combined with concurrent radiotherapy, followed by 6 cycles of temozolomide adjuvant chemotherapy, can prolong the patient's survival, and the 2-year survival rate has increased from 10.4% to 26.5%. Great progress has been made, but the prognosis for glioma patients remains poor. For patients with poor-quality high-grade gliomas, more effective new treatments are urgently needed to achieve the purpose of survival benefit. Targeting VEGFs to inhibit tumor angiogenesis has shown good efficacy in a variety of tumors including colon cancer, gastric cancer, lung cancer, liver cancer and breast cancer. However, for gliomas, anti-tumor angiogenesis drugs can improve patient OS Evidence related to PFS is still scarce. Compared with other targeted drugs with multiple kinase targets, apatinib has not only an advantage in price but also less side effects. Therefore, based on relevant data from previous studies, a basic and clinical study of this apatinib combined with temozolomide for high-grade gliomas was performed.

Conditions

• High-grade Gliomas

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib mesylate (0-14 days, 500 mg, qd), taken half an hour after a meal (the daily dose should be as much as possible), one week apart, and then given temozolomide (150mg/m2 for 5 Days); every 28 days is a cycle, medication to disease progression, intolerable toxicity, etc.

Timeline

• Start date: 2019-12-16
• Primary completion: 2021-12-30
• Completion: 2022-12-30
• First posted: 2020-02-05
• Last updated: 2020-02-05

Locations

1 site across 1 country: China