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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3- and 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
My colorectal cancer has not grown beyond the outer layer of the colon.
Select...
My colorectal cancer has spread to my liver.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Number of participants that drop out of study prior to receiving intervention (transplantation surgery) due to chemotherapy-related adverse events, as assessed by CTCAE v4.0
disease-free survival
patient survival
+4 moreTrial 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
1,476 Previous Clinical Trials
485,160 Total Patients Enrolled
Gonzalo Sapisochin, MDPrincipal InvestigatorUniversity Health Network, Toronto
5 Previous Clinical Trials
208 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research protocol for this investigation accommodate seniors aged 55 and above?
"To be accepted into this trial, individuals must fall within the age bracket of 18 to 68. 83 studies are available for those below 18 and 1721 studies cater to adults over 65 years old."
Answered by AI
What is the highest capacity of individuals involved in this medical experiment?
"Correct. Data hosted on clinicaltrials.gov confirms that this medical research, which was first posted on August 3rd 2016, is actively recruiting individuals to participate in the study. The trial currently needs 20 patients from 1 centre for completion."
Answered by AI
How can I become a participant in this research endeavor?
"This medical trial requires participants to have neoplasm metastasis, and fall between 18-68 years old. Approximately 20 patients are being recruited for the study."
Answered by AI
Are there any vacancies remaining for volunteers in this clinical trial?
"According to the clinicaltrials.gov information, this research project is seeking participants at present. It was initially posted on August 3rd 2016 and last revised on March 31st 2022."
Answered by AI
Who else is applying?
What site did they apply to?
Toronto General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- Toronto General Hospital: < 24 hours
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