NCT05185245 Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
| NCT ID | NCT05185245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Liver Metastasis Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2021-04-01 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 total hepatectomy. 5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. 6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed. In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05185245 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 73 Years, studying Liver Metastasis Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05185245 currently recruiting?
Yes, NCT05185245 is actively recruiting participants. Visit ClinicalTrials.gov or contact IRCCS Azienda Ospedaliero-Universitaria di Bologna to inquire about joining.
Where is the NCT05185245 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT05185245 clinical trial?
NCT05185245 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 20 participants.
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