Colorectal Carcinoma, Hepatic Metastasis
Conditions
Keywords
colorectal carcinoma, resectable hepatic metastasis, adjuvant treatment, dendritic cells
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.
Interventions
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free survival | Progression free survival at 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
Countries
Spain
Contacts
Primary ContactIgnacio Melero, MD, PHD
Outcome results
None listed