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

Sponsor
WuHui
Study ID
NCT04253873
Phase
PHASE2
Status
Unknown

Conditions

  • High-grade Gliomas

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 16, 2019
Status verified
Jan 2020
Primary completion
Dec 30, 2021
Completion
Dec 30, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib mesylate + temozolomide
    Apatinib mesylate tablets (0-14 days, 500 mg, qd), one week apart, then temozolomide (150mg/m2, 5 days);Every 28 days is a cycle, the drug until the disease progress, the toxicity of intolerable.

Primary Outcome Measure

6-month PFS rate [ Time Frame: up to 1 year ]

Central Contacts