Status:
RECRUITING
LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Conditions:
Colon Adenocarcinoma
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18-77 years
Phase:
NA
Brief Summary
This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors fo...
Detailed Description
Liver Transplant (LT) is a feasible, safe and effective curative strategy for patients with unresectable colorectal liver metastases (CRLM), and several trials are currently active and in a recruitmen...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05186116
Start Date
January 1 2022
End Date
January 1 2032
Last Update
September 25 2025
Active Locations (1)
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1
Azienda Ospedaliero Universitaria di Modena
Modena, MO, Italy, 41124