Liver transplantation for patients with non-resectable colorectal liver metastasis
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
This study is testing if liver transplants can help people with colorectal cancer that has spread to the liver and can't be removed, to see if it improves their chances of living longer and being cancer-free.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 73 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05185245 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with resected primary tumors and non-resectable liver metastasis who meet specific health criteria.
Not a fit: Patients with other malignancies or local recurrence of primary colon cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with non-resectable colorectal liver metastasis.
How similar studies have performed: While liver transplantation for colorectal liver metastasis is a novel approach, similar studies have shown promising results in select patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.