RecruitingPhase 1Phase 2NCT02215889

Partial Liver Segment 2/3 Transplantation Study

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

Sponsor

Oslo University Hospital

Enrollment

20 participants

Start Date

Jun 1, 2014

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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.