Partial Liver Segment 2/3 Transplantation Study

Colorectal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02215889
• Other study ID #: RAPID 2014
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2014
• Est. completion date: June 2028

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: Magnus Smedman, MD
• Phone: 23026600
• Email: torha[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2028
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Liver transplantation

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.		4 weeks
Secondary	Overall Survival		5 years