Liver Transplantation and Colorectal Cancer

Arm D: use of extended criteria donors (ECD)

Inclusion criteria

• 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 criteria

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