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The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.
There are three arms controlled group. First group receives standard medical theraphy (radiotherapy or chemoradiation), second group who receives autologous dendritic cell (Auto-DC), and third group receives the combination of allogenic-dendritic cell-secretomes (Allo-DC Secretome) and continued with autologous dendritic cell (Auto-DC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Aqua Pro-Injection) | Placebo Comparator | Subject will given 2 times injection of Aqua Pro-Injection via intramuscular (interval 2 days). |
|
| Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) | Experimental | Subject will given injection of Aqua Pro-Injection via intramuscular, two days after followed by Auto-DC via intramuscular. |
|
| Combination of Auto DC and Allo-DC-Secretome | Experimental | Subject will given injection of Allo-DC-Secretome via intramuscular, two days after followed by Auto-DC via intramuscular. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (Aqua Pro-Injection) | Other | Treatment with Aqua Pro-Injection 2 cc 2 times injection, interval 2 days (via Intramuscular). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Karnofsky Performance Status | To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. | Before therapy |
| Karnofsky Performance Status | To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. | 1 week after therapy |
| Karnofsky Performance Status | To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. | 1 month after therapy |
| Karnofsky Performance Status | To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. | 3 months after therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rima Haifa, B.Sc | Prodia Stem Cell Indonesia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT Prodia StemCell Indonesia | Jakarta | Indonesia |
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| Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) | Biological | Treatment with Aqua Pro-Injection 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular) |
|
| Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy) | Biological | Treatment with Allo-DC-Secretome 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular) |
|
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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