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| Name | Class |
|---|---|
| NewGenPharm Inc. | UNKNOWN |
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Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival probability of less than 5% when all stages are combined. At present, only approximately 10%-20% of patients are considered candidates for curative resection. The majority of patients (50%-60%) are present with metastatic disease, and substantial number of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.
Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of combination with standard chemotherapy with Theragene treatment is assessed in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theragene arm | Experimental | Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theragene®,Ad5-yCD/mutTKSR39rep-ADP | Biological | Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events assessed by CTCAE v4.03 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events assessed by CTCAE v4.03 | 12 weeks | |
| Tumor response | 8 weeks | |
| Time to disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32084409 | Derived | Lee JC, Shin DW, Park H, Kim J, Youn Y, Kim JH, Kim J, Hwang JH. Tolerability and safety of EUS-injected adenovirus-mediated double-suicide gene therapy with chemotherapy in locally advanced pancreatic cancer: a phase 1 trial. Gastrointest Endosc. 2020 Nov;92(5):1044-1052.e1. doi: 10.1016/j.gie.2020.02.012. Epub 2020 Feb 19. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000257 | Adenoviridae Infections |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 6.5 months |
| Detection of Infected Adenovirus in blood and urine assessed by PCR | 8 weeks |
| Detection of adenoviral DNA in blood by PCR | 8 weeks |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |