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NCT Number: NCT04616495

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Metastases Liver Neoplasms Metastatic Liver Cancer Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

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

Inclusion criteria

  • ≥ 18 and ≤ years
  • Good performance status, ECOG 0 or 1
  • Resected adenocarcinoma in colon or rectum (R0 resection)
  • Unresectable liver metastases
  • No extrahepatic disease
  • Normal blood tests
  • Response to ≤ 2 lines of chemotherapy (RECIST criteria)
  • ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list
  • Signed informed consent

Exclusion criteria

  • Body mass index ≥ 30
  • Positive HIV or HCV
  • Pregnancy at the time of inclusion
  • BRAF mutated status
  • Deterioration of general condition (10% weight loss in the prior 6 months)
  • Other malignancy with disease free survival < 5 years
  • Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.
  • Palliative resection of primary colorectal adenocarcinoma
  • Liver metastases size > 5 cm (in the last imaging technique)
  • CEA > 80 ng/ml (at time of enrolment in waiting list)
  • No neoadjuvant chemotherapy treatment
  • General contraindication to liver transplantation

Treatment and study plan

Liver Transplantation

Procedure

Chemotherapy and liver transplantation

Primary outcomes

  1. five year overall survival (OS)

    Time frame: 5 years

Secondary outcomes

  1. one year disease free survival (DFS)

    Time frame: 1 year

  2. three year disease free survival (DFS)

    Time frame: 3 years

  3. five year disease free survival (DFS)

    Time frame: 5 years

  4. Quality of life using EORTC questionnaires: QLQ-C30

    Time frame: 1 year

  5. Quality of life using EORTC questionnaires: QLQ-C30

    Time frame: 3 years

  6. Quality of life using EORTC questionnaires: QLQ-C30

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Eva M Montalvá, PhD

CONTACT

[email protected]

+34961245858

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Acronym: TRASMETIR

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Nov 5, 2020
Registry last updated
Sep 22, 2023

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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