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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Liver transplantation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Magnus Smedman, MD; Phone Number: 23026600; Email: torha@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0424 Oslo
    • Recruiting
    • Oslo University Hospital
    • Contact: Magnus Smedman, MD; Phone Number: +47 23026600; Email: torha@ous-hf.no
    • Principal Investigator: Magnus Smedman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery	Procedure: Liver transplantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	5 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimated): August 13, 2014

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Transplantation; Liver metastases
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: RAPID 2014