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Recruiting

NCT Number: NCT02215889

Partial Liver Segment 2/3 Transplantation Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oslo University Hospital

Oslo, 0424 Oslo, Norway

Location status: Recruiting

Location contact

Magnus Smedman, MD

CONTACT

[email protected]

23026600 ext. +47

Magnus Smedman, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liver Transplantation

Procedure

Primary outcomes

  1. Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.

    Time frame: 4 weeks

Secondary outcomes

  1. Overall Survival

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Magnus Smedman, MD

CONTACT

[email protected]

23026600

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2025
Study completion
2028
First posted
Aug 13, 2014
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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