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Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. Tumor treating fields (TTFields) is one of the standard combination treatment for GBM, and some researchers believe that TTFields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. In this study, the investigator attempts to evaluate the safety, and tolerability of TTFields in adult participants diagnosed with Drug/Radiation resistant BM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTFields group | Experimental | patients with brain metastases who have been resistant to drug or radiation therapy, to be treated by continuous TTFields treatment using the ASCLU-300 TTF device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASCLU-300 TTF | Device | BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA) |
|
| 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 brain metastases | 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 | |
|---|---|---|---|---|
| Fangkun Liu, MD | Contact | 8615874290600 | liufangkun@csu.edu.cn | |
| Liyang Zhang, MD | Contact | 8613787118459 | zhangliyang@csu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhixiong Liu, MD | Xiangya Hospital of Central South University | Principal Investigator |
| Yu Zeng | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410000 | China |
due to protect the patients' privacy, we have not yet decided to share each IPD, but we can share IPD once other researchers request upon approval by our Ethics Committee
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |