Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Colorectal Cancer Clinical Trial

— TRASMETIR  

Official title:

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616495
• Other study ID #: TRASMETIR
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 2028

Study information

• Verified date: September 2023
• Source: Hospital Universitario La Fe
• Contact: Eva M Montalvá, PhD
• Phone: +34961245858
• Email: montalva.oron[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2028
• Est. primary completion date: September 2026
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Metastases
• Liver Neoplasms
• Metastatic Liver Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• Liver transplantation
Chemotherapy and liver transplantation

Locations

Country	Name	City	State
Spain	Eva M Montalvá	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	five year overall survival (OS)		5 years
Secondary	one year disease free survival (DFS)		1 year
Secondary	three year disease free survival (DFS)		3 years
Secondary	five year disease free survival (DFS)		5 years
Secondary	Quality of life using EORTC questionnaires: QLQ-C30		1 year
Secondary	Quality of life using EORTC questionnaires: QLQ-C30		3 years
Secondary	Quality of life using EORTC questionnaires: QLQ-C30		5 years