Liver transplantation for patients with colorectal cancer that has spread to the liver
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
This study looks at whether liver transplants can help patients with colorectal cancer that has spread only to the liver live longer if their cancer was well-controlled by chemotherapy before the transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Fe Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Valencia) |
| Trial ID | NCT04616495 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the five-year overall survival rates of patients with unresectable liver-only colorectal metastases who have been well-controlled by chemotherapy prior to undergoing liver transplantation. It involves a multicentric approach where eligible patients will be monitored for their outcomes following the transplantation procedure. The study will focus on patients who meet specific criteria, including having a good performance status and no extrahepatic disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with unresectable liver metastases from colorectal cancer who have responded to chemotherapy.
Not a fit: Patients with extrahepatic disease, significant comorbidities, or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that significantly improves survival rates for patients with advanced colorectal cancer confined to the liver.
How similar studies have performed: While there have been studies on liver transplantation for metastatic colorectal cancer, this specific approach focusing on unresectable liver-only metastases is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 and ≤ years * Good performance status, ECOG 0 or 1 * Resected adenocarcinoma in colon or rectum (R0 resection) * Unresectable liver metastases * No extrahepatic disease * Normal blood tests * Response to ≤ 2 lines of chemotherapy (RECIST criteria) * ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list * Signed informed consent Exclusion Criteria: * Body mass index ≥ 30 * Positive HIV or HCV * Pregnancy at the time of inclusion * BRAF mutated status * Deterioration of general condition (10% weight loss in the prior 6 months) * Other malignancy with disease free survival \< 5 years * Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected. * Palliative resection of primary colorectal adenocarcinoma * Liver metastases size \> 5 cm (in the last imaging technique) * CEA \> 80 ng/ml (at time of enrolment in waiting list) * No neoadjuvant chemotherapy treatment * General contraindication to liver transplantation
Where this trial is running
Valencia
- Eva M Montalvá — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Eva M Montalvá, PhD
- Email: montalva.oron@gmail.com
- Phone: +34961245858
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.