Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Recruiting

• Conditions: Colorectal Cancer; Metastatic Liver Cancer; Liver Metastases
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT04616495
• Lead Sponsor: Hospital Universitario La Fe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Study Start: 2021-09-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2026-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver transplanted patients	Liver transplantation	-

Primary Outcome Measures

Name	Time	Method
five year overall survival (OS)	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eva M Montalvá; 🇪🇸 Valencia, Spain