Liver transplantation for colorectal cancer patients with liver metastases
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
This study is testing a new two-step surgery for colorectal cancer patients with liver tumors that can't be removed to see if it can help them live longer and feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oslo) |
| Trial ID | NCT02215889 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a two-stage surgical procedure for patients with colorectal cancer and liver metastases that cannot be surgically removed. Initially, liver segments 2 and 3 are removed from the patient and replaced with donor segments. After the donor segments have grown, the remaining liver segments of the patient are removed, leaving only the donor liver tissue. This innovative approach aims to improve outcomes for patients with advanced liver disease due to cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically verified colorectal adenocarcinoma and liver metastases that are not amenable to resection, with no signs of extrahepatic disease.
Not a fit: Patients with extensive extrahepatic metastatic disease or significant local recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a new treatment option for patients with colorectal cancer and liver metastases, potentially improving survival rates.
How similar studies have performed: While similar approaches have been explored, this specific method of partial liver transplantation for colorectal cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Magnus Smedman, MD
- Email: torha@ous-hf.no
- Phone: 23026600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.