Liver transplantation for patients with colorectal cancer liver metastases
Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases
This study is testing a new approach that combines surgery and liver transplantation to see if it can help patients with colorectal cancer that has spread to the liver live longer compared to standard chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Drugs / interventions | chemotherapy, Basiliximab |
| Locations | 2 sites (Jena and 1 other locations) |
| Trial ID | NCT03488953 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a two-stage hepatectomy combined with living donor liver transplantation for patients with irresectable liver metastases from colorectal cancer. The approach aims to achieve a complete tumor removal (R0 situation) by first performing a right portal vein ligation followed by a left-lateral liver transplantation. The study is designed as a one-arm trial without a control group, comparing outcomes to historical data from patients receiving standard chemotherapy. The primary endpoint is overall patient survival 36 months after the second stage of the procedure.
Who should consider this trial
Good fit: Ideal candidates are patients with stable disease from colorectal liver metastases without extrahepatic tumor burden, except for resectable lung metastases.
Not a fit: Patients with comorbidities that prevent liver transplantation or those with extrahepatic tumor spread may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a curative treatment option for patients with otherwise irresectable liver metastases.
How similar studies have performed: Previous studies have indicated that liver transplantation can be a feasible option for selected patients with colorectal liver metastases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with irresectable colorectal liver metastases without extrahepatic tumor burden, except resectable pulmonary metastases * stable disease or regression after at least eight weeks of systemic chemotherapy Exclusion Criteria: * comorbidities precluding liver transplantation * extrahepatic tumor spread, except resectable pulmonary metastases * progression during chemotherapy
Where this trial is running
Jena and 1 other locations
- Jena University Hospital — Jena, Germany (Recruiting)
- University Hospital Tübingen — Tübingen, Germany (Recruiting)
Study contacts
- Study coordinator: Falk Rauchfuss, M.D., M.Sc.
- Email: Falk.Rauchfuss@med.uni-jena.de
- Phone: 004936419322601
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.