Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHospital Universitario La Fe

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 and ≤ years

Good performance status, ECOG 0 or 1

Resected adenocarcinoma in colon or rectum (R0 resection)

Unresectable liver metastases

Disqualifiers

Body mass index ≥ 30

Positive HIV or HCV

Pregnancy at the time of inclusion

BRAF mutated status

Trial population

Cohort of patients detected in oncological units where they have been treated for colorectal cancer (stage IV with liver only unresectable metastases)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Liver transplantation

    Procedure/Surgery

    Chemotherapy and liver transplantation

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Liver transplanted patients1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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