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| Name | Class |
|---|---|
| Beijing GeneX Health Technology Co., Ltd | UNKNOWN |
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This trial is an open-label, single-arm, phase 0/1 study of high-grade glioma that aims to evaluate the feasibility, preliminary efficacy and safety of the precision treatment strategy.
The investigators have established a precision treatment strategy, that select chemotherapeutic drugs or targeted drugs based on information from PTCs drug-screening or/and bioinformatic prediction. In this study, the investigators are going to exploit this strategy for the precision treatment of recurrent high-grade gliomas. The investigators will evaluate the feasibility, safety and preliminary efficacy via collecting the indexes comprising clinical presentation, results of imaging examination, clinical assays, KPS, neurological score, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. | Experimental | These drugs included all the FDA-approved drugs that have been used in treating gliomas. A single drug or a drug combination for a specific patient will be recommended by the molecular tumor board, comprising neurooncologists, neurosurgeons, pharmacologists, cancer biologists, radiologists and bioinformaticians, will recommend , based on their expertise, patients willingness as well as evidences from PTCs-drug screening and bioinformatic prediction for drug response. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receiving chemotherapeutic or targeted drugs recommended by molecular tumor board. | Drug | Patients will be treated with FDA-approved chemotherapeutic or targeted drugs which were recommended by the molecular tumor board (MTB), based on their expertise, patients willingness as well as evidences from PTCs-drug screening and bioinformatic prediction for drug response. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients who accomplish the recommended regimen for at least 1 course. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (AEs) | AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | From the first shot to 4 weeks after the last shot |
| Ratio of 6 months overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Percentage of patients who survived more than 6 months from the date of surgery to death
| 6 months |
| Ratio of 12months overall survival (OS) | Percentage of patients who survived more than 12 months from the date of surgery to death | 12 months |
| Progression-free survival (PFS) | Progression-free survival, time from the date of surgery to any types of progression | 24 months |
| Overall survival (OS) | Overall survival, time from the date of surgery to death for whatever reason | 24 months |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |