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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Single-arm Phase II Study of Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177237
• Other study ID #: NPC-RN-001
• Status: Recruiting
• Phase: Phase 2
• Start date: July 28, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2021
• Source: Jiangxi Provincial Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Necrosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Xiaochang Gong	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	2-month response rate as determined by MRI and clinical symptoms	All of the patients were followed up with for 6 months.