NCT02864485 Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
| NCT ID | NCT02864485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2016-08-03 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2016-08-03 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor prognosis. In patients with resectable disease, surgery offers a distinct survival benefit. This study will offer live donor liver transplantation (LDLT) to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy. Potential participants will be evaluated for liver transplant suitability and must also have a willing, healthy living donor come forward for evaluation. Those participants who undergo LDLT will be followed for survival, disease-free survival and quality of life for 5 years and compared to a "control group" of participants who drop out of study prior to transplantation due to reasons other than cancer progression.
Eligibility 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
Contact & Investigator
Gonzalo Sapisochin, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT02864485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 68 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02864485 currently recruiting?
Yes, NCT02864485 is actively recruiting participants. Contact the research team at erin.winter@uhn.ca for enrollment information.
Where is the NCT02864485 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT02864485 clinical trial?
NCT02864485 is sponsored by University Health Network, Toronto. The principal investigator is Gonzalo Sapisochin, MD at University Health Network, Toronto. The trial plans to enroll 20 participants.
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