Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Recruiting · NCT04616495 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospital Universitario La Fe
View the official record on ClinicalTrials.gov →Interventions studied
Liver transplantation
What this trial is 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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Eva M Montalvá - Valencia, Spain