Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

Program Status

Recruiting

Phase

Not Applicable

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Chemotherapy

Tags

MSI-H/ MMRd, MSS/ MMRp
Location Location Status
Norway
Oslo University Hospital
Oslo
Recruiting

Contacts

Magnus Smedman, MD
Contact
23026600 torha@ous-hf.no
Maria Gjerde
Contact
+4723070000 mgjerde@ous-hf.no

Inclusion 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 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.

NCT ID

NCT03494946

Date Trial Added

2018-04-11

Updated Date

2024-02-06