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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007795-23 | EudraCT Number |
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In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | No Intervention | Observation after standard treatment | |
| Dendritic cells vaccine | Experimental | Adjuvant treatment with dendritic cells vaccine after standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic cells vaccine | Drug | Vaccination with autologous dendritic cells loaded with autologous tumor antigens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival | Progression free survival at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Melero, MD, PHD | Contact | +34 948 255 400 | imelero@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Ignacio Melero, MDPhD | University of Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30268156 | Derived | Rodriguez J, Castanon E, Perez-Gracia JL, Rodriguez I, Viudez A, Alfaro C, Onate C, Perez G, Rotellar F, Inoges S, Lopez-Diaz de Cerio A, Resano L, Ponz-Sarvise M, Rodriguez-Ruiz ME, Chopitea A, Vera R, Melero I. A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis. J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Hospital de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |