Liver Transplant or Chemotherapy for Colorectal Cancer Spread to the Liver
Compares liver transplant with chemotherapy in adults with colorectal cancer spread to the liver.
Plain-language title generated from the registry record
Registry title: Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
Key facts
- Where
- Oslo, NorwaySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer that has spread to the liver and cannot be removed by surgery, with no spread outside the liver. People are randomly assigned to a liver transplant or to chemotherapy and other treatments.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Adenocarcinoma of the colon or rectum with liver metastases that cannot be removed by liver surgery. No sign of cancer outside the liver or local relapse on scans, except lung spots that can be removed and are all smaller than 15mm. The cancer must be getting worse, or first-line chemotherapy was not tolerated.
- Earlier treatment
- People must have had first-line chemotherapy, and the cancer must have progressed or the chemotherapy was not tolerated. They must be randomized before the check 8-12 weeks after starting second-line chemotherapy.
Main reasons for not taking part
- Weight loss of more than 10% in the last 6 months
- BMI above 30
- Bone or brain/spinal cord (CNS) metastases, or metastatic lymph nodes in the chest or abdomen
- Previous breast cancer or malignant melanoma
- Primary colorectal tumor not removed, or only removed as palliative surgery
Read by machine on 12 November 2026.
Where in Norway
- Oslo University HospitalOslo, NorwayContact: Magnus Smedman, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT03494946
- Record updated
- 6 February 2024
- Original description
The trial is a randomized control trial. Patients are randomized between Ltx and other treatment that may include further chemotherapy, TACE, SIRT or other available treatment options. The patients will be randomized 1:1 to Ltx and chemotherapy/other treatment options.Read full original descriptionShow less
A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy
The trial is a randomized control trial. Patients are randomized between Ltx and other treatment that may include further chemotherapy, TACE, SIRT or other available treatment options. The patients will be randomized 1:1 to Ltx and chemotherapy/other treatment options.
Inclusion: Histologically verified adenocarcinoma in colon/rectum; Liver metastases, not amenable to liver resection; No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm; No signs of extra hepatic metastatic disease on CT or MRI thorax/abdomen/pelvis within 6 weeks prior to the faculty meeting at the transplant unit, except resectable lung lesions all < 15mm; No signs of extra hepatic metastatic disease on PET/CT within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all < 15mm; Good performance status, ECOG 0 or 1; Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<1.5 x upper normal level, ASAT, ALAT<5 x upper normal level, Creatinine <1.25 x upper normal level. Albumin above lower normal level; Signed informed consent and expected cooperation of the patients for the treatment and followup must be obtained and documented according to GCP, and national/local regulations; All patients should have progressive disease according to RECIST-criteria, or intolerance to 1. line chemotherapy. Patients must be randomized before evaluation 8-12 weeks after starting 2. line chemotherapy.
Exclusion: Previous resection of local relapse or non-hepatic metastasis within the last 2 years or resection of pulmonary or liver hilus lymph node metastases the last year; Previous diagnosed bone or CNS metastatic disease or thoracic or abdominal metastatic lymph nodes; Previous diagnosed cancer mammae or malignant melanoma; Non resected or palliative resection of primary CRC tumor; Weight loss >10% the last 6 months; Patient BMI > 30; Liver metastases affecting the diaphragm determined by CT-scan and/or ultrasound examination; Liver lesion>10cm; Three negative prognostic factors at time of randomization (CEA>80, less than 2 years from diagnosis, diameter of largest liver lesion >5.5cm); Any reason why, in the opinion of the investigator, the patient should not participate.