Actively Recruiting

Phase Not Applicable
Age: 18Years - 77Years
All Genders
NCT05186116

LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

Led by Azienda Ospedaliero-Universitaria di Modena · Updated on 2025-09-25

25

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM. Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life. Donor selection is performed according to the currently used Institutional and National standards and protocols.

CONDITIONS

Official Title

LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

Who Can Participate

Age: 18Years - 77Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed colon or rectal adenocarcinoma
  • Primary tumor classified as pT1-3 without peritoneal tumor deposits
  • No mucinous component greater than 50%
  • Confirmed complete (R0) resection of primary tumor
  • No limitations for RAS mutations; B-RAF wild type
  • No extra hepatic metastatic disease or local recurrence by CT, MRI, and PET/CT scans
  • Liver metastases not suitable for curative liver resection
  • Objective response or disease control according to RECIST 1.1 for at least 4 months
  • Stable or decreasing carcinoembryonic antigen (CEA) values before transplant
  • Performance status ECOG 0-2
  • Signed informed consent and expected cooperation for treatment and follow-up
Not Eligible

You will not qualify if you...

  • Hereditary colorectal cancer syndromes including familial adenomatous polyposis (FAP) and Lynch syndrome
  • Prior extra hepatic metastatic disease or local recurrence of primary tumor
  • Palliative resection of primary colorectal tumor
  • Disease progression
  • Other malignancies within the last 5 years except in situ cervical carcinoma or basal cell carcinoma
  • Active intravenous drug or alcohol abuse without demonstrated abstention for more than 6 months
  • Active HIV infection
  • Psychiatric disorders or low patient compliance
  • Any investigator judgment reason preventing participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Azienda Ospedaliero Universitaria di Modena

Modena, MO, Italy, 41124

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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