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Taking people in NorwayPhase 1/2

Tests partial liver transplant with later full liver removal in colorectal cancer

Tests a two-stage liver transplant in adults with colorectal cancer that spread to the liver.

Plain-language title generated from the registry record
Registry title: Partial Liver Segment 2/3 Transplantation Study

Key facts

Where
Oslo, NorwaySee the site
Phase
Phase 1/2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with colorectal cancer that has spread to the liver and cannot be removed by surgery, with no cancer outside the liver apart from a few small lung spots.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Colon or rectal adenocarcinoma confirmed under the microscope, with liver metastases that cannot be removed by liver resection. No cancer outside the liver on scans, except 1-3 removable lung lesions all smaller than 15mm. No local recurrence of the cancer.
Earlier treatment
At least 8 weeks of chemotherapy before joining.

Main reasons for not taking part

  • Weight loss of more than 10% in the last 6 months
  • BMI above 30
  • Earlier diagnosed bone or brain/spinal cord (CNS) metastases
  • Earlier diagnosed breast cancer or malignant melanoma
  • Palliative (symptom-relief) surgery to remove the primary colorectal tumor

Read by machine on 9 November 2026.

Where in Norway

  • Oslo University HospitalOslo, NorwayTaking people

Questions to ask the study team

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  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Oslo University Hospital
Trial code
NCT02215889
Record updated
6 February 2024
Original description
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.Read full original descriptionShow less

A Phase I/II Clinical Trial to Evaluate the Benefit and Efficacy of Liver Resection And Partial Liver Segment 2/3 Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma

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.

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

ClinicalTrials.gov NCT02215889