Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

Recruiting now · Not applicable

Conditions studied: Liver Metastases, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT03494946

Run by

Oslo University Hospital

People needed

30

Starts

2016-12-05

Expected to finish

2027-01-01

Last updated by the study team

2024-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Oslo University Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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