Icotinib Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors (Icotinib)
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ClinicalTrials.gov Identifier: NCT02934256 |
Recruitment Status : Unknown
Verified February 2017 by Li Peng, Beijing Tiantan Hospital.
Recruitment status was: Recruiting
First Posted : October 14, 2016
Last Update Posted : February 9, 2017
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Condition or disease | Intervention/treatment | Phase |
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Vestibular Schwannoma Neurofibromatosis Type 2 | Drug: Icotinib | Phase 2 |
Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression.
Previous studies of NF2 patients treated with Erlotinib suggested that inhibition of epidermal growth factor receptor (EGFR) could result in hearing improvement and reduction in tumor size.
Much evidence implicates human epidermal growth factor (HER) receptors in vestibular schwannoma growth.Some studies have demonstrated that Merlin, the NF2 gene protein product, controls surface availability of the EGFR, ErbB2, and ErbB3 receptors in human and Drosophila models. Besides, cell culture models of mouse embryo fibroblasts (MEFs) support the role of EGFR in NF2-associated tumorigenesis. Nf2-deficient cells in culture lack contact-dependent inhibition of growth and continue to grow in confluent cultures. This effect appears to be mediated by EGFR signaling. Treatment of Nf2-deficient cells with EGFR inhibitors such as gefitinib can restore contact-dependent inhibition, suggesting that this class of drugs might be useful for NF2 patients with progressive vestibular schwannomas. In this way, Icotinib can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of Icotinib on NF2.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors |
Study Start Date : | July 2016 |
Estimated Primary Completion Date : | January 2018 |
Estimated Study Completion Date : | June 2018 |

Arm | Intervention/treatment |
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Experimental: Icotinib,treatment effect evaluation
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.
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Drug: Icotinib
Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.
Other Name: Icotinib Hydrochloride Tablets |
- Change from Baseline in volume of tumour after every course of the treatment [ Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12 ]Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.
- Change from Baseline in hearing ability after every course of the treatment [ Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12 ]Patients' hearing ability would be tested after every course of the treatment.
- Change from baseline in QOL(quality of life) score after every course of the treatment [ Time Frame: Baseline,Month 3,Month 6,Month 9,Month 12 ]Patients' QOL(quality of life) would be evaluated after every course of the treatment.

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Ages Eligible for Study: | 16 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must be at the age of 16-50
- Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors
- Patients must not be treated with other drugs or radiation therapy recently
- Patients should live in Beijing or nearby and can be treated in hospital
- Patients must be healthy and not be seriously allergic with biological agents
- Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.
Exclusion Criteria:
- Treated with other drugs, surgery or radiation therapy recently
- Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time
- Being pregnant or try to get pregnant, lactating women
- With acute or chronic infectious diseases
- With heart diseases, cardiac dysfunction or abnormal ECG
- With uncontrolled neural or mental diseases, poor compliance
- Not available for enhanced MRI
- Take part in any other clinical trial
- With other conditions that are considered not suitable for this clinical trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934256
Contact: Pinan Liu | +86 010 67096865 | liupinan@hotmail.com | |
Contact: Fu Zhao | +86 010 67096775 | talentzf@hotmail.com |
China, Beijing | |
Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting |
Beijing, Beijing, China, 100050 | |
Contact: Pinan Liu +86 010 67096865 liupinan@hotmail.com | |
Principal Investigator: Fu Zhao | |
China | |
Beijing Tiantan Hospital Affiliated to Capital Medical University | Recruiting |
Beijing, China, 100050 | |
Contact: Pinan Liu +86 010 67096865 liupinan@hotmail.com | |
Principal Investigator: Fu Zhao |
Study Director: | Pinan Liu | Beijing Tiantan Hospital | |
Principal Investigator: | Fu Zhao | Beijing Neurosurgical Institute |
Responsible Party: | Li Peng, principal investigator, Beijing Tiantan Hospital |
ClinicalTrials.gov Identifier: | NCT02934256 |
Other Study ID Numbers: |
Tian-drug-neuro002 |
First Posted: | October 14, 2016 Key Record Dates |
Last Update Posted: | February 9, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Neurofibromatosis Type 2 Vestibular Schwannoma Other NF2-related tumors |
Neurofibromatoses Neurofibromatosis 1 Neurofibroma Neurilemmoma Neuroma, Acoustic Neurofibromatosis 2 Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Nervous System Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases |
Genetic Diseases, Inborn Peripheral Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Neoplasms Nervous System Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroma Cranial Nerve Neoplasms Neoplasms by Site Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases |