Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04616495

Acronym

TRASMETIR

Enrollment

Registered

2020-11-05

Start date

2021-09-01

Completion date

2028-09-30

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Liver Metastases, Metastatic Liver Cancer

Brief summary

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.

Interventions

PROCEDURELiver transplantation

Chemotherapy and liver transplantation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
five year overall survival (OS)	5 years

Secondary

Measure	Time frame
one year disease free survival (DFS)	1 year
three year disease free survival (DFS)	3 years
five year disease free survival (DFS)	5 years
Quality of life using EORTC questionnaires: QLQ-C30	1 year

Countries

Spain

Contacts

Primary ContactEva M Montalvá, PhD

montalva.oron@gmail.com+34961245858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026