Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

• Status: Recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Liver Extracts

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 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.