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Partial Liver Segment 2/3 Transplantation Study

Partial Liver Segment 2/3 Transplantation Study

Recruiting
18 years and older
All
Phase 1/2

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Overview

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.

Eligibility

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 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.

Exclusion Criteria:

  • 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.

Study details
    Colorectal Cancer

NCT02215889

Oslo University Hospital

16 February 2024

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