Overview

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

Status:
Recruiting
Trial end date:
2025-12-30
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. detailed description:
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangxi Provincial Cancer Hospital
Treatments:
Endostar protein
Criteria
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.