Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT04616495
Eligibility Criteria:
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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04616495
Study Brief:
Protocol Section:
NCT04616495