Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-03 @ 10:18 PM
Study NCT ID:
NCT01348256
Status:
UNKNOWN
Last Update Posted:
2017-10-24
First Post:
2011-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-23', 'studyFirstSubmitDate': '2011-05-03', 'studyFirstSubmitQcDate': '2011-05-04', 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free survival', 'timeFrame': 'Progression free survival at 2 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal carcinoma', 'resectable hepatic metastasis', 'adjuvant treatment', 'dendritic cells'], 'conditions': ['Colorectal Carcinoma', 'Hepatic Metastasis']}, 'referencesModule': {'references': [{'pmid': '30268156', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age over 18 years.\n2. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.\n3. Capacity of understanding and signing the informed consent and to undergo the study procedures\n4. Availability of tumor tissue, for maturing dendritic cells\n5. Adequate renal, hepatic and bone marrow function\n\nExclusion Criteria:\n\n1. Clinically relevant diseases or infections.\n2. Concurrent participation in other clinical trial or administration or other antitumoral treatment\n3. Concurrent cancer, with the exceptions allowed by the principal investigator (PI).\n4. Pregnant or breast feeding women\n5. Immunosuppressant treatment'}, 'identificationModule': {'nctId': 'NCT01348256', 'briefTitle': 'Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma', 'orgStudyIdInfo': {'id': 'CD-2009-01'}, 'secondaryIdInfos': [{'id': '2008-007795-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Observation after standard treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Dendritic cells vaccine', 'description': 'Adjuvant treatment with dendritic cells vaccine after standard treatment', 'interventionNames': ['Drug: Dendritic cells vaccine']}], 'interventions': [{'name': 'Dendritic cells vaccine', 'type': 'DRUG', 'description': 'Vaccination with autologous dendritic cells loaded with autologous tumor antigens', 'armGroupLabels': ['Dendritic cells vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio Melero, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ruth Vera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'centralContacts': [{'name': 'Ignacio Melero, MD, PHD', 'role': 'CONTACT', 'email': 'imelero@unav.es', 'phone': '+34 948 255 400'}], 'overallOfficials': [{'name': 'Ignacio Melero, MDPhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}