Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

Completed

• Conditions: Colorectal Liver Metastases

• Registration Number: NCT02615665
• Lead Sponsor: University of Milan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-24
• Last Update Submitted: 2015-11-24
• Study First Posted: 2015-11-26
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (1)

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan; 🇮🇹 Rozzano, Milan, Italy