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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Endostar

• Registration Number: NCT05177237
• Lead Sponsor: Jiangxi Provincial Cancer Hospital

Brief Summary

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

detailed description:

Detailed 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.

Study Timeline

• Study Start: 2021-07-28
• Status Verified: 2021-12
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Last Update Submitted: 2021-12-15
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar combined with Methylprednisolone	Endostar	Endostar combined with Methylprednisolone lasts for 10 weeks

Primary Outcome Measures

Name	Time	Method
ORR	All of the patients were followed up with for 6 months.	2-month response rate as determined by MRI and clinical symptoms

Trial Locations

Locations (1)

Xiaochang Gong; 🇨🇳 Nanchang, Jiangxi, China