Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Carcinoma, Hepatic Metastasis
Both
Colorectal Carcinoma, Hepatic Metastasis
Trial Information
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
Inclusion Criteria:
1. Age over 18 years.
2. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for
surgical treatment.
3. Capacity of understanding and signing the informed consent and to undergo the study
procedures
4. Availability of tumor tissue, for maturing dendritic cells
5. Adequate renal, hepatic and bone marrow function
Exclusion Criteria:
1. Clinically relevant diseases or infections.
2. Concurrent participation in other clinical trial or administration or other
antitumoral treatment
3. Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
4. Pregnant or breast feeding women
5. Immunosuppressant treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free survival
Outcome Time Frame:
Progression free survival at 2 years
Safety Issue:
No
Principal Investigator
Ignacio Melero, MDPhD
Investigator Role:
Study Chair
Investigator Affiliation:
Universidad de Navarra
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
CD-2009-01
NCT ID:
NCT01348256
Start Date:
November 2010
Completion Date:
June 2014
Related Keywords:
- Colorectal Carcinoma
- Hepatic Metastasis
- colorectal carcinoma
- resectable hepatic metastasis
- adjuvant treatment
- dendritic cells
- Carcinoma
- Colorectal Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
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