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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05177237
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jiangxi Provincial Cancer Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Nasopharyngeal Carcinoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Endostar combined with Methylprednisolone

Endostar combined with Methylprednisolone lasts for 10 weeks

Interventions

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.

Contact a Trial Team

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International Sites

Xiaochang Gong, Nanchang, Jiangxi, China

Status

Recruiting

Address

Xiaochang Gong

Nanchang, Jiangxi, 330000

Site Contact

Gong X Xiaochang, MD

[email protected]

+8613970020755

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