Clinical trial · Interventional
Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
NCT02934256CI-TRIAL-00053772IcotinibcompletedPhase 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)
1)Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of Icotinib; 3)Provide an objective basis for an enlarged randomized double-blind trial.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 2 | — | UNRESOLVED | — |
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib，treatment effect evaluation
- description
- Patients use Icotinib hydrochloride tablets during the course of treatment. The drug dosage is 125mg/m3/d. Every course of treatment lasts three months. Patients are designed to receive total four courses of treatment if there is no disease progression.
- interventionNames
- Drug: Icotinib
Primary outcomes (1)
- measure
- Change from Baseline in volume of tumour after every course of the treatment
- timeFrame
- Baseline,Month 3,Month 6,Month 9,Month 12
- description
- Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.
Secondary outcomes (1)
- measure
- Change from Baseline in hearing ability after every course of the treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be at the age of 16-50 2. Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors 3. Patients must not be treated with other drugs or radiation therapy recently 4. Patients should live in Beijing or nearby and can be treated in hospital 5. Patients must be healthy and not be seriously allergic with biological agents 6. Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent. Exclusion Criteria: 1. Treated with other drugs, surgery or radiation therapy recently 2. Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time 3. Being pregnant or try to get pregnant, lactating women 4. With acute or chronic infectious diseases 5. With heart diseases, cardiac dysfunction or abnormal ECG 6. With uncontrolled neural or mental diseases, poor compliance 7. Not available for enhanced MRI 8. Take part in any other clinical trial 9. With other conditions that are considered not suitable for this clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.