Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

Summary

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.

Eligibility

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.

Conditions5

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