Clinical trial NCT05177237: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Endostar
Radiation-induced Brain Necrosis
Nasopharyngeal Carcinoma
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: ORR
timeFrame: All of the patients were followed up with for 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Xiaochang Gong
state: Jiangxi
Study officials:
References: