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Procedure
Liver Transplant for Bile Duct Cancer
N/A
Waitlist Available
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
Patients must have ≥ 6 months of disease stability or tumor regression on gemcitabine-based therapy. For patients who have progressed to second-line therapy, disease must also be controlled for ≥ 6 months on that regimen
Disease is deemed unresectable based on tumor location or underlying liver dysfunction
Must not have
Pregnant or breast-feeding patients (unless willing to abstain from breast-feeding)
Known history of human immunodeficiency virus (HIV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is for patients with intrahepatic cholangiocarcinoma who have achieved 6 months of disease stability while receiving standard chemotherapy. If eligible, they will be listed for transplantation. After transplantation, they will be followed for disease recurrence and overall survival.
Who is the study for?
This trial is for adults with advanced bile duct cancer (iCCA) that can't be removed by surgery. They must have shown no cancer growth or shrinkage for at least 6 months on chemotherapy, be in good physical condition (ECOG score: 0 or 1), and have a potential living donor. People with other cancers, HIV, poor kidney function, or who are pregnant/breastfeeding cannot join.
What is being tested?
The study is testing liver transplantation as a treatment option for patients with stable advanced intrahepatic cholangiocarcinoma who aren't currently eligible for this procedure. Participants will undergo standard pre-transplant evaluations and post-transplant follow-ups to monitor disease recurrence and survival.
What are the potential side effects?
Liver transplantation can lead to complications such as rejection of the new organ, infections due to immunosuppressive drugs taken after transplant, bleeding issues, blood clots forming in liver arteries or veins, bile duct problems like leaks or strictures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not worsened for at least 6 months while on gemcitabine or a second-line therapy.
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My condition cannot be treated with surgery due to the tumor's location or liver issues.
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I have maintained good physical health since joining the study.
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My cancer is intrahepatic cholangiocarcinoma confirmed by tissue analysis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding, or I am willing to stop breastfeeding.
Select...
I have been diagnosed with HIV.
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I have had a solid organ or bone marrow transplant in the past.
Select...
My kidneys are not working well, with a creatinine clearance under 50 ml/min.
Select...
I have had radiation or localized treatment on my tumor.
Select...
My cancer has spread beyond the liver and affects other areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: liver transplantationExperimental Treatment1 Intervention
Surgical Intervention - Liver transplantation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liver Transplantation
2010
N/A
~4760
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,527 Previous Clinical Trials
503,536 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
30 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Gonzalo Sapisochin, MDPrincipal InvestigatorUHN
5 Previous Clinical Trials
218 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
30 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of substance abuse or any medical, psychological, or social conditions that may affect your ability to take part in the study or could affect the study results.I am not pregnant or breastfeeding, or I am willing to stop breastfeeding.I have been diagnosed with HIV.My cancer has not worsened for at least 6 months while on gemcitabine or a second-line therapy.My condition cannot be treated with surgery due to the tumor's location or liver issues.I have had a solid organ or bone marrow transplant in the past.I am 18 years old or older.My kidneys are not working well, with a creatinine clearance under 50 ml/min.I have had radiation or localized treatment on my tumor.I do not have any health conditions that could make this study unsafe for me.I agree to use birth control if I can become pregnant.My cancer has spread beyond the liver and affects other areas.I have maintained good physical health since joining the study.My cancer is intrahepatic cholangiocarcinoma confirmed by tissue analysis.I have had cancer before, but it might still be okay.
Research Study Groups:
This trial has the following groups:- Group 1: liver 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.