Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    30
  • sponsor
    Jiangxi Provincial Cancer Hospital
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Updated on 21 March 2022
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renal function
corticosteroids
carcinoma
methylprednisolone
blood cell count
nasopharyngeal carcinoma

Summary

To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients.

detailed description:

Description

This was a single-arm, open-label study. We aimed to evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. Magnetic resonance imaging (MRI) was performed pre- and post-treatment to define the radiographic response.The primary outcome was a 2-month response rate as determined by MRI and clinical symptoms. All of the patients were followed up with for 6 months.

Details
Condition Nasopharyngeal Carcinoma
Treatment Endostar
Clinical Study IdentifierNCT05177237
SponsorJiangxi Provincial Cancer Hospital
Last Modified on21 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Cytologically or histologically proven Nasopharyngeal Carcinoma(WHO 2003 I-III)
Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region
age ≥18 years
radiation therapy history for histologically confirmed NPC administered≥6 months prior to study entry
radiographic evidence to support the diagnosis of RN with out tumor recurrence or metastases
patients had never received Antiangiogenic agents for RN treatment prior to the screening
patients had never received corticosteroids for RN treatment prior to the screening
no evidence of very high intracranial pressure suggestive of a brain hernia requiring surgery routine laboratory studies including urinalysis, complete blood count, liver function, renal function, and coagulation test within a normal range
to understand and be willing to sign a written informed consent

Exclusion Criteria

Other types of Nasopharyngeal Carcinoma
Recurrent nasopharyngeal carcinoma, resection of encephalopathy, metastasis, hepatitis, other malignant tumors, neurovascular diseases, or other diseases of the nervous system
Inadequately controlled diabetes (FBG > 10mmol/L) and hypertension(systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
Other severe concurrent disorders that occurred before enrollment (severe or unstable angor, NYHA class 3 or 4 congestive heart failure, Myocardial infarction occurred within 6 months before enrollment；Aortic dissection aortic aneurysm.) active central nervous system hemorrhage
pregnant or lactating women, women who have not undergone a pregnancy test (within 14 days prior to initial administration), and pregnant women
Patients with a history of severe mental illness or communication disorders
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