Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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.

More Liver Metastases trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorJena University Hospital
Academic / other
Drugs / interventionschemotherapy, Basiliximab
Locations2 sites (Jena and 1 other locations)
StatusRecruiting
StartedApril 10, 2018
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedJuly 31, 2024
Trial IDNCT03488953 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.