Living donor liver transplant for patients with non-resectable colorectal cancer 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 interventional study evaluates the effectiveness of living donor liver transplantation (LDLT) in patients with unresectable colorectal liver metastases (CRLM). It aims to assess overall and disease-free survival rates, as well as graft survival and donor outcomes. Patients will undergo a thorough screening process to determine eligibility based on specific criteria related to their cancer status and overall health. The study will follow patients through pre-transplant screening and the transplantation process, ensuring adherence to established protocols.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18.
* Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
* Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component \>50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.
* No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans.
* Liver metastases not eligible for curative liver resection
* Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete \[CR\] or partial response \[PR\] or standard disease \[SD\]) during second- line treatment for at least 4 months.
* Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.
* Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2.
* Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations.

Exclusion Criteria:

* Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.
* Prior extra hepatic metastatic disease or primary tumor local relapse.
* Palliative resection of primary CRC tumor.
* Disease progression
* Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).
* Active intra-venous or alcohol abusers (patients may be eligible if abstention \> 6 months is demonstrated)
* Active HIV infection
* Psychiatric disorders and patient low compliance
* Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)

Where it's running

• Azienda Ospedaliero Universitaria di Modena
  Modena, Mo, 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.