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

NCT ID: NCT05177237

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2025-12-30

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endostar combined with Methylprednisolone

Endostar combined with Methylprednisolone lasts for 10 weeks

Group Type: EXPERIMENTAL

Endostar

Intervention Type: DRUG

Endostar: 210 mg (14 PCS) continuous infusion for 168h, Q3W, 4 cycles. Methylprednisolone: 80mg intravenously, once daily, for 3-5 days, gradually reduced to 10mg/ day oral maintenance dose.

Interventions

Endostar

Endostar: 210 mg (14 PCS) continuous infusion for 168h, Q3W, 4 cycles. Methylprednisolone: 80mg intravenously, once daily, for 3-5 days, gradually reduced to 10mg/ day oral maintenance dose.

Intervention Type: DRUG

Other Intervention Names

Re-human endostain

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiaochang Gong

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Gong X Xiaochang, MD

Role: primary

gxcanddw@sina.com

+8613970020755

Other Identifiers

NPC-RN-001

Identifier Type: -

Identifier Source: org_study_id