Actively Recruiting
Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
Led by University Health Network, Toronto · Updated on 2024-06-18
20
Participants Needed
1
Research Sites
747 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must reside in Canada
- ECOG score of 0-1 before liver transplant (occasional score of 2 allowed)
- Confirmed colorectal cancer liver metastases
- Able and willing to provide written informed consent
- Negative pregnancy test for women who can become pregnant
- Both men and women must use effective birth control during the trial
- At least one ABO-compatible healthy living donor available
- Primary colorectal cancer tumor stage T4a or less
- At least 6 months between colorectal cancer surgery and transplant
- Liver metastases are bilateral and cannot be removed by surgery
- No major blood vessel invasion and metastases limited to the liver
- Received systemic chemotherapy for at least 3 months
- Stable or shrinking liver metastases for at least 3 months before screening
- Stable or decreasing carcinoembryonic antigen (CEA) levels before transplant
You will not qualify if you...
- Previous or current cancer except some allowed types
- Prior lung surgery
- Progression of liver metastases before transplant
- Kidney dysfunction with creatinine clearance under 50 ml/min
- Lung problems affecting breathing
- History of heart disease
- Known HIV or chronic hepatitis B or C infection
- Severe neuropathy greater than grade 2
- Tumors positive for BRAF mutation
- Any unstable condition that risks patient safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
Research Team
E
Erin Winter, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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