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| Name | Class |
|---|---|
| Belarusian State Medical University | OTHER |
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The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer
The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.
Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.
The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dendritic cells lysate-pulsed group | Experimental | Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate |
|
| Control group | No Intervention | Patients treated according to clinical protocols | |
| Dendritic cells peptide-pulsed group | Experimental | Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic cells pulsed with tumor lysate | Biological |
| ||
| Dendritic cells pulsed with MUC-1/WT-1 peptides |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with PR or CR at 1 year | 1 year PR/CR | 1 year |
| Number of Participants Who Survived at 1 Year | 1 year overall survival | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Antigen-specific immune response | The increase of antigen-specific T-cells | 1 year |
| Circulating tumor cells count | Decrease of EpCAM+CD45- circulating tumor cells count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander V. Prokharau, Prof. | Belarussian State Medical University, Minsk, Belarus | Study Director |
| Andrei Y Hancharou, Dr. | The Republican Research and Practical Center for Epidemiology and Microbiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minsk City Clinical Oncologic Dispensary | Minsk | 220000 | Belarus |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Biological |
|
| 1 year |
| Immune response | Decrease of T-regulatory cells | 1 year |
| Number of Participants Who Survived at 2 Years | 2 year overall survival | 2 years |
| Number of Participants Who Survived at 3 Years or more | 3 year overall survival | 3 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |