Effect and Safety of Apatinib on Radiation-Induced Brain Injury

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• Male or female patients aged ≥35 years;

• Prior radiotherapy for histologically confirmed head and neck cancer ≥12 months prior to study entry;

• Radiographic evidence to support the diagnosis of radiation-induced brain injury without tumor recurrence;

• Estimated life expectancy must be greater than 12 months;

• Routine laboratory studies：Bilirubin ≤ 1.0 × upper limits of normal (ULN)； Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.0 × ULN；Creatinine <1.0 × ULN；White-cell count ≥ 4,000 cells per cubic millimeter；Neutrophils count ≥1500 cells per cubic millimeter；Platelets ≥100,000 cells per cubic millimeter；Hemoglobin ≥110 gram per milliliter；Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) within the normal ranges；

• With sufficient cognitive function and language skills for communication and completion of study questionnaires;

• Consent the enrollment of the study.

Exclusion Criteria:

• Evidence of tumor metastasis, recurrence, or invasion;

• Current usage of bevacizumab;

• Current usage of glucocorticoids;

• Evidence of very high intracranial pressure that suggests brain hernia and the need for surgery;

• History of psychiatric disease before radiotherapy;

• History of seizures;

• History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infarction, and unstable angina, within 6 months;

• Present or previous history of cardiac arrhythmia;

• New York Heart Association Grade II or greater congestive heart failure;

• Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, and history of aortic dissection;

• Severe infection;

• History of allergy to relevant drugs;

• Pregnancy, lactation, or fertility program in the following 12 months;

• History or current diagnosis of peripheral nerve disease;

• Abnormal liver and renal function;

• Active tuberculosis;

• A previous history of organ transplantation;

• Infection with the human immunodeficiency virus;

• Participation in other experimental studies;

• Subjects with any other condition which in the investigator's judgment might intervene the outcome of the study.