Partial Liver Segment 2/3 Transplantation Study

Recruiting now · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor segments 2-3, the remaining liver segments of the recipient are removed. The patient will at this time have only donor liver tissue in place.

Key facts

Study ID

NCT02215889

Run by

Oslo University Hospital

People needed

20

Starts

2014-06-01

Expected to finish

2028-06-01

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 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all<15mm.
• No signs of extra hepatic metastatic disease on CT thorax/abdomen/pelvis within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all<15mm.
• No local recurrence according to MR-pelvis scan in patients with rectal cancer 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.
• 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.
• All patients should have received at least 8 weeks of chemotherapy.

You may not qualify if…

• Weight loss >10% the last 6 months
• Patient BMI > 30
• Previous diagnosed bone or CNS metastatic disease.
• Previous diagnosed cancer mammae or malignant melanoma.
• Palliative resection of primary CRC tumor.

Where it is running

• Oslo University Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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