Liver transplantation for patients with non-resectable colorectal liver metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of liver transplantation in patients with non-resectable colorectal liver metastasis. It focuses on assessing overall survival as the primary endpoint and disease-free survival as a secondary endpoint. Patients will be considered for various types of liver transplants, including whole or partial grafts from deceased or living donors. The study aims to provide a new treatment option for patients who have limited alternatives due to the nature of their cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
* Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
* No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
* No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
* Good performance status Eastern Cooperative Oncology Group 0 or 1
* Neutrophils \> 1.000
* Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours
* Carcino-Embryonic Antigen \< 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
* Written informed consent
* No other contraindications to liver transplantation

Exclusion Criteria:

* Presence of other malignancies
* Local recurrence of primary tumor
* Extra-hepatic metastatic disease
* Patients who did not receive any neoadjuvant or adjuvant therapy
* Palliative resection of primary tumor
* Any other reason, according to the investigators, that could be a contraindication to protocol enrollment

Where it's running

• IRCCS Azienda Ospedaliero - Universitaria di Bologna
  Bologna, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.