Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostar
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Endostar, Radiation-induced Brain Necrosis, Nasopharyngeal Carcinoma
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.
Sites / Locations
- Xiaochang GongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endostar combined with Methylprednisolone
Arm Description
Endostar combined with Methylprednisolone lasts for 10 weeks
Outcomes
Primary Outcome Measures
ORR
2-month response rate as determined by MRI and clinical symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT05177237
First Posted
December 15, 2021
Last Updated
December 15, 2021
Sponsor
Jiangxi Provincial Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05177237
Brief Title
Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
Official Title
A Single-arm Phase II Study of Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Provincial Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Endostar, Radiation-induced Brain Necrosis, Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endostar combined with Methylprednisolone
Arm Type
Experimental
Arm Description
Endostar combined with Methylprednisolone lasts for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
Re-human endostain
Intervention Description
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.
Primary Outcome Measure Information:
Title
ORR
Description
2-month response rate as determined by MRI and clinical symptoms
Time Frame
All of the patients were followed up with for 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Xiaochang Gong
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gong X Xiaochang, MD
Phone
+8613970020755
Email
gxcanddw@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
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