Partial Liver Segment 2/3 Transplantation Study

Phase 1

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT02215889
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Liver transplantation	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway