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

NCT05177237 | Unknown Phase 2 DMC

• 1 other identifier: NPC-RN-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Carcinoma

Keywords

Endostar; Radiation-induced Brain Necrosis; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  2-month response rate as determined by MRI and clinical symptoms

  All of the patients were followed up with for 6 months.

Study Arms (1)

Endostar combined with Methylprednisolone

EXPERIMENTAL

Endostar combined with Methylprednisolone lasts for 10 weeks

Drug: Endostar

Interventions

Endostar 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.

Also known as: Re-human endostain

Endostar combined with Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Xiaochang Gong

Nanchang, Jiangxi, 330000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

endostar protein

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: July 28, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)