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

Phase 2

• Conditions: Hepatic Metastasis; Colorectal Carcinoma
• Interventions: Drug: Dendritic cells vaccine

• Registration Number: NCT01348256
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-24
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dendritic cells vaccine	Dendritic cells vaccine	Adjuvant treatment with dendritic cells vaccine after standard treatment

Primary Outcome Measures

Name	Time	Method
Progression Free survival	Progression free survival at 2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years

Trial Locations

Locations (2)

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Navarra, Spain