Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma

University of Navarra

Status and phase: Unknown; Phase 2

Conditions: Colorectal Carcinoma; Hepatic Metastasis

Treatments: Drug: Dendritic cells vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01348256

2008-007795-23 (EudraCT Number)

CD-2009-01

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Observation

No Intervention group

Description:

Observation after standard treatment

Dendritic cells vaccine

Experimental group

Description:

Adjuvant treatment with dendritic cells vaccine after standard treatment

Treatment:

Drug: Dendritic cells vaccine