Liver transplantation for patients with colorectal cancer liver metastases
Official title: Living Donor Liver Transplantation With Two Stage Hepatectomy for Patients With Isolated, Irresectable Colorectal Liver Metastases
Run by Jena University Hospital · NCT03488953 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Jena University Hospital Academic / other |
| Drugs / interventions | chemotherapy, Basiliximab |
| Locations | 2 sites (Jena and 1 other locations) |
| Status | Recruiting |
| Started | April 10, 2018 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | July 31, 2024 |
| Trial ID | NCT03488953 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with stable disease from colorectal liver metastases without extrahepatic tumor burden, except for resectable lung metastases.
✕Probably not a fit
Patients with comorbidities that prevent liver transplantation or those with extrahepatic tumor spread may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.