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

Sponsor
Jiangxi Provincial Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05177237
Collaborator
(none)
30
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Study Details

Study Description

Brief Summary

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

detailed description:

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm Phase II Study of Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
Actual Study Start Date :
Jul 28, 2021
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endostar combined with Methylprednisolone

Endostar combined with Methylprednisolone lasts for 10 weeks

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.
Other Names:
  • Re-human endostain
  • Outcome Measures

    Primary Outcome Measures

    1. ORR [All of the patients were followed up with for 6 months.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xiaochang Gong Nanchang Jiangxi China 330000

    Sponsors and Collaborators

    • Jiangxi Provincial Cancer Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangxi Provincial Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05177237
    Other Study ID Numbers:
    • NPC-RN-001
    First Posted:
    Jan 4, 2022
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jiangxi Provincial Cancer Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2022