Clinical trial · Interventional
Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
A Single-arm Phase II Study of Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
NCT05177237CI-TRIAL-00055781unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. detailed description:
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostar combined with Methylprednisolone
- description
- Endostar combined with Methylprednisolone lasts for 10 weeks
- interventionNames
- Drug: Endostar
Primary outcomes (1)
- measure
- ORR
- timeFrame
- All of the patients were followed up with for 6 months.
- description
- 2-month response rate as determined by MRI and clinical symptoms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.