Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

Colorectal Liver Metastases Clinical Trial

Official title:

Role of CD3+ and NKp46+ Cells in Resected Colorectal Liver Metastases.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615665
• Other study ID #: NKTCellsInCLM
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: November 24, 2015
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The long-term outcome of patients resected for colorectal liver metastases (CLM) after neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the CHT. The aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for CLM after CHT in regards to the long-term outcome.

Description:

The immunoreactivity to CD3+ and NKp46+ cells inside the tumor, at the border between the tumor and the normal liver, and inside the normal liver will be tested by computer-assisted image analyses in patients undergoing liver resection for CLM between 2005 and 2013 preoperatively treated with oxaliplatin or irinotecan with or without bevacizumab or cetuximab. The survival will be assessed in relation to several prognostic factors and to that immunoreactivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histological proven colorectal liver metastases

• complete clinical, surgical, pathological and follow-up data

Exclusion Criteria:

• non-radical surgery

• incomplete clinical, surgical, pathological and follow-up data

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Hepatic resection
Removal of a part of the liver during surgery

Locations

Country	Name	City	State
Italy	Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Hudspeth K, Donadon M, Cimino M, Pontarini E, Tentorio P, Preti M, Hong M, Bertoletti A, Bicciato S, Invernizzi P, Lugli E, Torzilli G, Gershwin ME, Mavilio D. Human liver-resident CD56(bright)/CD16(neg) NK cells are retained within hepatic sinusoids via — View Citation

Hudspeth K, Pontarini E, Tentorio P, Cimino M, Donadon M, Torzilli G, Lugli E, Della Bella S, Gershwin ME, Mavilio D. The role of natural killer cells in autoimmune liver disease: a comprehensive review. J Autoimmun. 2013 Oct;46:55-65. doi: 10.1016/j.jaut — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 years	No