Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
2 other identifiers
interventional
58
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2010
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 24, 2017
October 1, 2017
8.1 years
May 3, 2011
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free survival
Progression free survival at 2 years
Secondary Outcomes (1)
Overall survival
2 years
Study Arms (2)
Observation
NO INTERVENTIONObservation after standard treatment
Dendritic cells vaccine
EXPERIMENTALAdjuvant treatment with dendritic cells vaccine after standard treatment
Interventions
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
Eligibility Criteria
You may qualify if:
- Age over 18 years.
- Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
- Capacity of understanding and signing the informed consent and to undergo the study procedures
- Availability of tumor tissue, for maturing dendritic cells
- Adequate renal, hepatic and bone marrow function
You may not qualify if:
- Clinically relevant diseases or infections.
- Concurrent participation in other clinical trial or administration or other antitumoral treatment
- Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
- Pregnant or breast feeding women
- Immunosuppressant treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Related Publications (1)
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.
PMID: 30268156DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ignacio Melero, MDPhD
University of Navarra
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 5, 2011
Study Start
November 1, 2010
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 24, 2017
Record last verified: 2017-10