Liver Transplantation and Colorectal Cancer

Prior treatment

• 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 illness

• Other malignancies

Other

• Weight loss \>10% the last 6 months
• Patient BMI \> 30
• Any reason why, in the opinion of the investigator, the patient should not participate.

• 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.