Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases

• Sponsor: University of Milan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02615665
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Duration (Months): 30.9
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Liver Metastases	Procedure: Hepatic resection

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 Design

• Study Type: Observational
• Actual Enrollment: 121 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Role of CD3+ and NKp46+ Cells in Resected Colorectal Liver Metastases.
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Outcome Measures

Primary Outcome Measures

1. Overall survival [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan	Rozzano	Milan	Italy	20089

Sponsors and Collaborators

• University of Milan

Investigators

• Principal Investigator: Guido Torzilli, MD, PhD, Humanitas University, Humanitas Research Hospital IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
• ClinicalTrials.gov Identifier: NCT02615665
• Other Study ID Numbers: NKTCellsInCLM
• First Posted: Nov 26, 2015
• Last Update Posted: Nov 26, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Prof. Guido Torzilli, Professor of Surgery, University of Milan: NK-cells; T-cells
• Additional relevant MeSH terms: Neoplasm Metastasis; Liver Neoplasms

Study Results

No Results Posted as of Nov 26, 2015