The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases

Inclusion criteria

• Patients with non-resectable, non-ablatable liver metastases from colorectal adenocarcinoma.
• Male or female 18 years or above.
• Primary tumour removed with an R0 resection, and histologically verified adenocarcinoma from colon or rectum
• Liver metastases measurable by MRI or CT according to RECIST version 1.1 Imaging within 4 weeks prior to inclusion.
• No signs of extrahepatic metastatic disease or local recurrence according to MRI and CT of thorax/abdomen and whole body Positron-emission tomography (PET)/ computed tomography (CT) scan.
• A colonoscopy performed within the last 12 months in order to exclude multifocal colorectal cancer (CRC) tumours.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Satisfactory blood tests: Hb ≥ 90 g/L (transfusions are permitted to achieve baseline hemoglobin level), White blood cell Count (WBC) >3,0x109/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet Count (PLT) >75, Bilirubin<2 x upper normal level, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT)<5 x upper normal level, Calculated Creatinine clearance ≥ 50 mL/min(MDRD).
• Received at least 2 months of chemotherapy with no signs of progressive disease according to RECIST-criteria at the last evaluation before randomization.
• One year or more from the initial CRC diagnosis to the date of inclusion in the study
• Patient accepted for transplantation by a national study board
• Signed and dated written informed consent before the start of specific protocol procedures.

Exclusion criteria

• Evidence of extrahepatic disease by PET-CT or CT-thorax/abdomen.
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
• Weight loss >10% the last 6 months
• Other malignancies within the last 5 years, except CRC and low risk tumours such as basaliomas.

• Liver metastases larger than 10 cm.
• Pathological lymphatic nodes in the abdomen. If a patient has pathological lymphatic nodules in the hepatoduodenal ligament, a staging operation with histo-pathological examination from the nodules with no signs of tumour cell involvement has to be performed before inclusion.
• BRAF (a gene that encodes a protein called b-raf) mutation in primary tumour
• microsatellite instability (MSI-H) in primary tumour
• Previous organ transplantation