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OpenTrials
Completed

NCT Number: NCT02615665

Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Rozzano, Milan, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hepatic resection

Procedure

Removal of a part of the liver during surgery

Other names: Hepatectomy; liver resection; liver surgery

Primary outcomes

  1. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2015
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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