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Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Sponsored by Hospital Universitario La Fe

About this trial

Last updated 2 years ago

Study ID

TRASMETIR

Status

Recruiting

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Trial Timing

Started 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting