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Procedure
Live Donor Liver Transplantation for Colorectal Cancer Liver Metastases
N/A
Recruiting
Led By Gonzalo Sapisochin, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient has undergone systemic chemotherapy (eg. FOLFOX +/- bevacizumab or FOLFIRI +/- bevacizumab) for ≥3 months
Bilateral and non-resectable LM
Must not have
Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
Patients with debilitating neuropathy (CTCAE > grade 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3- and 5 years
Awards & highlights
Summary
This trial will offer live donor liver transplantation to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy.
Who is the study for?
This trial is for Canadian residents with colorectal cancer that has spread to the liver and can't be removed by surgery. Participants need a willing, compatible living donor for liver transplant, stable or improving cancer markers on chemotherapy, and good physical function (ECOG score 0-1). Pregnant women and those not using birth control are excluded.
What is being tested?
The study tests live donor liver transplantation in patients whose colorectal cancer has spread only to the liver and isn't getting worse on standard chemo. It compares survival rates of these patients post-transplant against those who leave the study before receiving a transplant.
What are the potential side effects?
Potential side effects include complications from major surgery like bleeding, infection, rejection of the new liver, anesthesia risks, and immunosuppression-related issues such as increased risk of infections or other cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with chemotherapy for at least 3 months.
Select...
My liver metastases cannot be surgically removed and are in both lobes.
Select...
My cancer has only spread to my liver and hasn't invaded major blood vessels.
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My colorectal cancer has not grown beyond the outer layer of the colon.
Select...
My colorectal cancer has spread to my liver.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidneys are not working well, with a low creatinine clearance rate.
Select...
I do not have severe nerve pain or damage.
Select...
I have a history of HIV or chronic hepatitis B/C.
Select...
My tumor is BRAF positive.
Select...
I have trouble breathing or lung problems.
Select...
I have had surgery to remove part of my lung.
Select...
My liver metastasis progressed before my transplant surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-, 3- and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3- and 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
self-reported quality of life as assessed by EORTC QLQ-C30 questionnaire
survival of intervention vs standard treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: transplantationExperimental Treatment1 Intervention
Live donor liver transplantation for the treatment of unresectable colorectal cancer liver metastases
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,185 Total Patients Enrolled
Gonzalo Sapisochin, MDPrincipal InvestigatorUniversity Health Network, Toronto
5 Previous Clinical Trials
208 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mostly been active and able to care for myself before my liver transplant.My kidneys are not working well, with a low creatinine clearance rate.I have a history of heart disease.I do not have severe nerve pain or damage.I have been treated with chemotherapy for at least 3 months.I agree to use effective birth control during the trial.I have a history of HIV or chronic hepatitis B/C.My liver metastases have not worsened in the past 3 months.My tumor is BRAF positive.My liver metastases cannot be surgically removed and are in both lobes.My cancer has only spread to my liver and hasn't invaded major blood vessels.I have trouble breathing or lung problems.I have had cancer before or have another cancer now.I have had surgery to remove part of my lung.I agree to use effective birth control during the trial.My colorectal cancer has not grown beyond the outer layer of the colon.I have mostly been active and able to care for myself before my liver transplant.My liver metastasis progressed before my transplant surgery.My colorectal cancer has spread to my liver.It has been 6 months or more since my colon cancer surgery.I do not have any health conditions that could make this study unsafe for me.At least 1 donor has stepped forward.My colorectal cancer has spread to my liver.
Research Study Groups:
This trial has the following groups:- Group 1: transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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