Effect and Safety of Apatinib on Radiation-Induced Brain Injury

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT04152681
Phase
PHASE2
Status
Unknown

Conditions

  • Radiation Injuries

Eligibility Criteria

Sex
ALL
Age
35 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib with a dosage of 250mg once daily for 4 weeks, in the absence of unacceptable toxicity or severe deterioration.

Study Details

Purpose: This early phase 2 clinical trial aims to evaluate the therapeutic effects and safety of apatinib in radiation-induced brain injury. Further study details as provided by Sun Yet-sen Memorial Hospital, Sun Yat-sen University / Yamei Tang. Primary outcome measure: The proportion of patients with an objective response defined as ≥ 25% reduction in brain edema volume on MR fluid attenuated inversion recovery (FLAIR) images.

Key Dates

Start date
Oct 17, 2019
Status verified
Nov 2019
Primary completion
Feb 29, 2020
Completion
Mar 31, 2020

Study Design

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

Arms

  • Experimental: Assigned Interventions
    Apatinib with a dosage of 250mg once daily for 4 weeks, in the absence of unacceptable toxicity or severe deterioration.

Primary Outcome Measure

Overall efficacy rate [ Time Frame: 4 weeks ]

Central Contacts

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