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Procedure
Liver Transplantation for Bile Duct Cancer (LT for iCCA Trial)
Phase 2
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
Eastern Cooperative Oncology Group: 0 or 1 at all times prior to Liver Transplantation
Patient not eligible for liver resection due to poor liver function/portal hypertension
Must not have
Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
Uncontrolled infection(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate the effectiveness of liver transplant as a treatment for very early intrahepatic cholangiocarcinoma (iCCA) diagnosed in cirrhotic patients.
Who is the study for?
This trial is for patients with very early-stage intrahepatic cholangiocarcinoma (iCCA) who have cirrhosis and are not candidates for liver resection. They must be in good physical condition (ECOG 0 or 1), without cancer symptoms, no vascular or biliary involvement, no extra-hepatic disease, and CA 19.9 levels ≤100 ng/mL. Exclusions include significant cardiac disease, renal dysfunction, HIV infection, prior organ transplants or iCCA treatments.
What is being tested?
The study tests the effectiveness of deceased donor liver transplantation as a potential cure for 'very early' iCCA in cirrhotic patients ineligible for resection surgery. Participants may receive bridging therapies before transplant and will be monitored over five years to assess survival rates and disease recurrence.
What are the potential side effects?
Liver transplantation can lead to complications such as rejection of the new liver by the body's immune system, infections due to immunosuppressive drugs required after surgery, bleeding issues, bile duct complications like leaks or strictures, and possible recurrence of cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have always been fully active or restricted in physically strenuous activity only.
Select...
I cannot have liver surgery due to poor liver function or high blood pressure in the liver.
Select...
My bile duct cancer is very early stage and the tumor is 2 cm or smaller.
Select...
I do not have symptoms caused by my cancer.
Select...
I have liver cirrhosis.
Select...
My liver cancer was caught very early.
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 any infections that are not responding to treatment.
Select...
My tumor has grown larger than 3 cm or has spread outside the liver.
Select...
I have had a solid organ transplant.
Select...
I have been diagnosed with HIV.
Select...
My current tumor is a recurrence after having liver surgery for cancer.
Select...
I have trouble breathing or lung problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Liver
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
The intervention will consist of liver transplantation
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,521 Previous Clinical Trials
503,274 Total Patients Enrolled
3 Trials studying Liver Cancer
51 Patients Enrolled for Liver Cancer
Gonzalo Sapisochin, MDPrincipal InvestigatorUniversity Health Network, Toronto
5 Previous Clinical Trials
198 Total Patients Enrolled
Jordi Bruix, MDPrincipal InvestigatorHospital Clinic of Barcelona
3 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant or breastfeeding.I have always been fully active or restricted in physically strenuous activity only.My kidneys are not working well, with a low creatinine clearance rate.I have a history of heart disease.I do not have any infections that are not responding to treatment.I have had cancer before or have another type of cancer now.I cannot have liver surgery due to poor liver function or high blood pressure in the liver.My tumor has grown larger than 3 cm or has spread outside the liver.I have had a solid organ transplant.I do not have any health conditions that could make participating in this study unsafe for me.I have been diagnosed with HIV.My current tumor is a recurrence after having liver surgery for cancer.My bile duct cancer is very early stage and the tumor is 2 cm or smaller.I have trouble breathing or lung problems.I do not have symptoms caused by my cancer.I have liver cirrhosis.My liver cancer was caught very early.
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.
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