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.