Partial Liver Segment 2/3 Transplantation Study

NCT02215889 | Recruiting Phase 1

• 1 other identifier: RAPID 2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Liver metastases; Transplantation

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

• Overall Survival

  5 years

Study Arms (1)

Surgery

EXPERIMENTAL

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424 Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Central Study Contacts

Magnus Smedman, MD

CONTACT

23026600; torha@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: August 13, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

NO (1)