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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Treatments: Vaccines

Criteria

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