Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Liver Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Hepatic resection

Removal of a part of the liver during surgery

Intervention Type PROCEDURE

Other Intervention Names

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Hepatectomy; liver resection; liver surgery

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Guido Torzilli

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guido Torzilli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Humanitas University, Humanitas Research Hospital IRCCS

Locations

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Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Rozzano, Milan, Italy

Site Status

Countries

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Italy

References

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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 the engagement of CCR5 and CXCR6 pathways. J Autoimmun. 2016 Jan;66:40-50. doi: 10.1016/j.jaut.2015.08.011. Epub 2015 Aug 30.

Reference Type RESULT

PMID: 26330348 (View on PubMed)

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.2013.07.003. Epub 2013 Jul 21.