Liver Transplant vs Chemotherapy for Colorectal Cancer
Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer
Recruiting
N/AInterventional Study
Liver MetastasesColorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Oslo University Hospital · Other
Who this trial is looking for
This trial is looking for patients with colorectal cancer that has spread to the liver. Participants will be randomly assigned to receive either a liver transplant or other treatments, including chemotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with colorectal cancer.
I have liver metastases that cannot be surgically removed.
I have no signs of cancer spreading to other parts of my body.
I have a good performance status.
I have satisfactory blood test results.
I have progressive disease according to RECIST criteria.
I have not had significant weight loss.
I have signed informed consent to participate.
You may not be able to join if
I have lost more than 10% of my weight in the last 6 months.
My body mass index (BMI) is over 30.
I have had surgery for cancer in the last 2 years.
I have been diagnosed with bone or brain cancer.
I have previous breast cancer or malignant melanoma.
I have not had my primary colorectal tumor surgically removed.
My liver metastasis is affecting the diaphragm.
My largest liver lesion is larger than 10 cm.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 pa…
Inclusion Criteria:
* 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 Criteria:
* Weight loss \>10% the last 6 months
* Patient BMI \> 30
* 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.
* 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.
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