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Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

RecruitingNAAges 18 Years - 73 YearsAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT05185245 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors. Type of different transplantations proposed are as follows: 1. Whole liver graft or partial liver (split) from a deceased donor 2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. 3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. 4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed

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📋 Eligibility rules (as published)
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
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What it tests

  • Liver Transplantation
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Where

1 site
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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