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| Name | Class |
|---|---|
| Hunan An Tai Kang Cheng Biotechnology Co., Ltd | UNKNOWN |
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This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.
Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric Fields Treatment System to subjects with recurrent GBM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor Electric Fields Treatment System | Experimental | Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Electric Fields Treatment System | Device | Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The treatment-related adverse events | Number of patients who experienced a treatment-related adverse event. | 12 months |
| Time to Progression | Time to progression of patients with recurrent glioblastoma. | 12 months |
| Overall Survival Rate | Number of patients alive at 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhixiong Liu, M.D. | Contact | +8613607318785 | zhixiongliu@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |