Overview
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.
Eligibility
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.