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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02215889

Enrollment

Registered

2014-08-13

Start date

2014-06-30

Completion date

2028-06-30

Last updated

2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Liver metastases, Transplantation

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.

Interventions

PROCEDURELiver transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Overall Survival	5 years

Countries

Norway

Contacts

Primary ContactMagnus Smedman, MD

torha@ous-hf.no23026600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026