Liver transplant versus liver surgery for colorectal cancer spread to the liver
Compares liver transplant with liver surgery in adults with colorectal cancer in the liver.
Plain-language title generated from the registry record
Registry title: Liver Transplantation and 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 whose colorectal cancer has spread only to the liver and who have had at least 3 cycles of chemotherapy without the lesions growing. Some are assigned to liver transplantation, others to liver surgery.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Adenocarcinoma of the colon or rectum with liver metastases and no signs of spread outside the liver or local return of the cancer on scans. Some groups need 6 or more liver metastases that surgery could remove, or metastases that surgery cannot remove. One group needs an expected survival of 6-12 months without a liver transplant.
- Earlier treatment
- At least 3 cycles of chemotherapy (6 weeks of treatment), with no increase in size of the lesions. Standard surgery with adequate margins for the primary tumour. Some groups need at least 10% response to first-, second- or third-line chemotherapy.
- Biomarker or test result
- Some groups need CEA below 100 ng/ml at the time of first diagnosis and at the time liver metastases were found, and the primary tumour classified as pN0.
Main reasons for not taking part
- Weight loss of more than 10% in the last 6 months
- BMI above 30
- Other cancers
- Earlier spread outside the liver or local return of the cancer
- Palliative removal of the primary tumour
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
- NCT01479608
- Record updated
- 7 February 2024
- Original description
Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.Read full original descriptionShow less
A Randomized Controlled Clinical Trial to Evaluate the Benefit and Efficacy of Liver Transplantation as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma
Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.
The investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results.
The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection.
The investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.
Inclusion: Histologically verified adenocarcinoma in colon or rectum; No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan; No signs of extra hepatic metastatic disease or local recurrence according to CT or MR (thorax/abdomen/pelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit; No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit; Good performance status, ECOG 0 or 1; Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, ASAT,ALAT<5 x upper normal level, ,Creatinine <1.25 x upper normal level. Albumin above lower normal level; Standard surgical procedure with adequate resection margins including circumferential resection margins (CRM) of at least ≥2mm for rectal cancer patients; Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations; Received at least 3 cycles of chemotherapy (6 weeks of treatment), with no increase in size of the lesions according to RECIST-criteria; Additional inclusion criteria for patients included in part A:; Six or more liver metastases technically resectable; Additional inclusion criteria for patients included in part B:; Metachronous liver metastases (more than 12 months from diagnosis of CRC and/or end of adjuvant treatment); Pathological classification of primary tumor as pN0 disease; CEA<100 ng/ml at time of primary diagnosis as well as at time of diagnosis of metastatic disease; Liver metastases not eligible for curative liver resection; Before start of 1. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less; At least 10% response (RECIST-criteria) on 1. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 1. line chemotherapy; Additional inclusion criteria for patients included in part C:; Liver metastases not eligible for curative liver resection; Received 1.line treatment; Before start of 2. or 3. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less; At least 10% response (RECIST-criteria) on 2. or 3. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 2. or 3. line chemotherapy; Two years or more time span from the CRC diagnosis and date of being listed on the transplantation list; Additional inclusion criteria for patients included in part Arm D:; Patients with expected overall survival of 6-12 months without a liver transplant; The patient might be included without further chemotherapy treatment. Patients may have resectable pulmonary lesions at time of inclusion in the present study.
Exclusion: Prior extra hepatic metastatic disease or local relapse; Patients who have not received standard pre-operative, per-operative or post-operative treatment for the primary CRC; Palliative resection of primary CRC tumor; Previous randomization in this trial; Other malignancies; Weight loss >10% the last 6 months; Patient BMI > 30; Any reason why, in the opinion of the investigator, the patient should not participate.