Treatment for brain damage caused by radiation in nasopharyngeal carcinoma patients

A Single-arm Phase II Study of Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma

This study is testing if a combination of Endostar and corticosteroids can help people with nasopharyngeal carcinoma who have brain damage from radiation feel better and improve their symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangxi Provincial Cancer Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT05177237 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of Endostar combined with corticosteroids for treating radiation-induced brain necrosis in patients with nasopharyngeal carcinoma. It is a single-arm, open-label study where patients undergo magnetic resonance imaging (MRI) before and after treatment to assess radiographic response. The primary outcome is the response rate at two months, based on MRI results and clinical symptoms, with follow-up lasting six months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with cytologically or histologically proven nasopharyngeal carcinoma and evidence of radiation-induced brain necrosis.

Not a fit: Patients with other types of nasopharyngeal carcinoma or those who have received prior treatments for radiation necrosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and quality of life for patients suffering from radiation-induced brain necrosis.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating radiation-induced complications, suggesting potential for success.

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.

Where this trial is running

Nanchang, Jiangxi

• Xiaochang Gong — Nanchang, Jiangxi, China (Recruiting)

Conditions Nasopharyngeal Carcinoma; Endostar; Radiation-induced Brain Necrosis