Living donor liver transplantation for patients with colorectal cancer liver metastases
Assessment of a Protocol Using a Combination of Neo-adjuvant Chemotherapy Plus Living Donor Liver Transplantation for Non-Resectable Liver Metastases From Colorectal Cancer
This study is testing if living donor liver transplants can help people with colorectal cancer that has spread to the liver live longer and have a better quality of life compared to those who don’t get the transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 68 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT02864485 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of living donor liver transplantation (LDLT) for patients with unresectable liver metastases from colorectal cancer. Participants must have metastases limited to the liver and stable on standard chemotherapy. The study aims to determine the survival rates and quality of life for those who undergo LDLT compared to a control group of patients who drop out for reasons other than cancer progression. The study will follow participants for five years post-transplantation to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with stable, unresectable liver metastases from colorectal cancer who have a willing and healthy living donor.
Not a fit: Patients with rapidly progressing liver metastases or those without a suitable living donor will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that significantly improves survival rates for patients with unresectable liver metastases from colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with living donor liver transplantation for similar conditions, but this study aims to refine the criteria for better outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must reside in Canada * ECOG ( Eastern Cooperative Oncology Group) score : 0-1 at all times prior to LDLT (excursions to ECOG 2 allowed at investigator's discretion) * Proven colorectal Liver Metastases (LM). * Willing and able to provide written informed consent. * Negative serum pregnancy test for women of childbearing potential * Both men and women must agree to use adequate barrier birth control measures during the course of the trial. * At least 1 "acceptable", ABO-compatible living donor has stepped forward * Primary Colorectal cancer tumor stage is ≤T4a * Time from primary CRC resection to transplant is ≥6 months * Bilateral and non-resectable LM * No major vascular invasion by LM; metastases isolated to liver * The patient has undergone systemic chemotherapy (eg. FOLFOX +/- bevacizumab or FOLFIRI +/- bevacizumab) for ≥3 months * demonstrated stability or regression of LM over at minimum the 3 months preceding screening * Carcinoembryonic Antigen (CEA) values are stable or decreasing at all timepoints prior to the transplant surgery. Exclusion Criteria: * Previous or concurrent cancer (with some exceptions) * prior lung resection * Progression of LM at any timepoint prior to transplant surgery * Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min * Pulmonary insufficiency * History of cardiac disease * Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B and/or C infection. * Patients with debilitating neuropathy. (CTCAE \> grade 2) * BRAF + tumors * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Where this trial is running
Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gonzalo Sapisochin, MD — University Health Network, Toronto
- Study coordinator: Erin Winter, BSc
- Email: erin.winter@uhn.ca
- Phone: 416-340-4800
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.