Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT04616495

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Led by Hospital Universitario La Fe · Updated on 2023-09-22

30

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.

CONDITIONS

Official Title

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • Good performance status, ECOG 0 or 1
  • Resected adenocarcinoma in colon or rectum with R0 resection
  • Unresectable liver metastases
  • No extrahepatic disease
  • Normal blood tests
  • Response to up to 2 lines of chemotherapy (RECIST criteria)
  • At least 1 year since colorectal cancer diagnosis before enrollment
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Body mass index 30 or higher
  • Positive HIV or HCV infection
  • Pregnancy at time of inclusion
  • BRAF mutated status
  • General condition deterioration (10% weight loss in prior 6 months)
  • Other malignancy with disease-free survival less than 5 years
  • Concomitant or prior extrahepatic metastases, even if surgically removed
  • Palliative resection of primary colorectal adenocarcinoma
  • Liver metastases larger than 5 cm on recent imaging
  • CEA level over 80 ng/ml at enrollment
  • No neoadjuvant chemotherapy treatment
  • General contraindications to liver transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Eva M Montalvá

Valencia, Spain, 46026

Actively Recruiting

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Research Team

E

Eva M Montalvá, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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