TMZ Plus Apatinib in Newly Diagnosed High-grade Glioma：RCT
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
Glioma is the most common primary malignant Brain Tumor. Although the traditional treatment
(surgery, radiotherapy and chemotherapy) has been actively carried out, the curative effect
of High grade glioma (HGG) is still poor.On the basis of a lot of exploration, the union
medication has become a hot spot. Malignant glioma has obvious neovascularization and
inhibiting angiogenesis can inhibit tumor proliferation and invasion.Studies have found that
inhibiting VEGFR-2 can can reduce neovascularization and inhibit tumor growth. NCCN clinical
practice guidelines recommend bevacizumab(BEV) for the treatment of recurrent malignant
gliomas. AVAglio＆RTOG 0825 subgroup analysis showed that TMZ combined with antiangiogenic
drugs may have advantages in the first-line treatment of patients with IDH1 wild-type high
grade glioma.However, some studies have shown that bevacizumab can lead to rapid
deterioration due to hypoxia or phenotypic changes. So it is urgent to find new
antiangiogenic drugs. Apatinib is an oral small molecule antiangiogenic targeted drug.
Apatinib plus temozolomide has been shown to be effective and tolerable in recurrent glioma.
So the investigators aimed to evaluate the efficacy and safety of temozolomide combined with
apatinib in the new diagnosis of high-grade glioma，and to explore the new first-line
treatment of HGG, especially to TMZ insensitivity patients(MGMT gene promoter unmethylated)
and poor prognosis (IDH1 wild type) population. And Find out the benefit groups of the two
drugs.