← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

LT for iCCA Trial 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.Check my eligibility

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.See study design

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.

LT for iCCA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

LT for iCCA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

5 year patient survival

Secondary outcome measures

Liver

LT for iCCA Trial Design

1Treatment groups

Experimental Treatment

Group I: Liver transplantationExperimental Treatment1 Intervention

The intervention will consist of liver transplantation

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,974 Total Patients Enrolled

1 Trials studying Intrahepatic Cholangiocarcinoma

10 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Gonzalo Sapisochin, MDPrincipal InvestigatorUniversity Health Network, Toronto

5 Previous Clinical Trials

198 Total Patients Enrolled

1 Trials studying Intrahepatic Cholangiocarcinoma

10 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Jordi Bruix, MDPrincipal InvestigatorHospital Clinic of Barcelona

3 Previous Clinical Trials

130 Total Patients Enrolled

1 Trials studying Intrahepatic Cholangiocarcinoma

89 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Media Library

Deceased donor Liver Transplantation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02878473 — Phase 2

Intrahepatic Cholangiocarcinoma Research Study Groups: Liver transplantation

Intrahepatic Cholangiocarcinoma Clinical Trial 2023: Deceased donor Liver Transplantation Highlights & Side Effects. Trial Name: NCT02878473 — Phase 2

Deceased donor Liver Transplantation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02878473 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment for this clinical trial progressing?

"Verification can be found on clinicaltrials.gov confirming that this clinical trial, which was initially published on April 5th 2018, is actively recruiting. 30 participants must be drawn from one site for the study's completion."

Answered by AI

Are individuals able to apply for this research endeavor at present?

"Affirmative, clinicaltrials.gov indicates that this experiment is actively recruiting patients as of April 8th 2022; the trial was initially listed on April 5th 2018. 30 people are required to take part in this study at a single medical centre."

Answered by AI

Are persons below the age of sixty being considered for inclusion in this research program?

"According to the terms of this clinical trial, patient eligibility is based on their age: those 18-65 are welcome to enroll."

Answered by AI

Is Deceased donor Liver Transplantation a risk-free method of treatment?

"Our team has assigned a score of 2 to Deceased donor Liver Transplantation due to the fact that only limited safety data is available, but no efficacy evidence for this Phase 2 trial."

Answered by AI

Are there any eligibility criteria for participation in this trial?

"This trial is seeking 30 adult human subjects with cholangiocarcinoma, aged 18 to 65. To qualify for the clinical study, they must not be eligible for liver resection due to compromised hepatic function or portal hypertension; have a biopsy-verified "very early" intrahepatic cancer (iCCA); meet Eastern Cooperative Oncology Group criteria of 0 or 1 at all times before transplantation; show no symptoms related to their cancer diagnosis; possess cirrhosis from any etiology; provide written informed consent; and bear a negative pregnancy test in women of childbearing age. Furthermore, imaging assessments"

Answered by AI

Recent research and studies

HepatologyJournal

Liver Transplantation for “very Early

Sapisochin, G., M. Facciuto, L. Rubbia-Brandt, J. Marti, N. Mehta, F.Y. Yao, E. Vibert, et al.. 2016. “Liver Transplantation for “very Early” Intrahepatic Cholangiocarcinoma: International Retrospective Study Supporting a Prospective Assessment”. Hepatology. Wiley. doi:10.1002/hep.28744.

clinicaltrials.govStudy

Liver Transplantation for Early Intrahepatic Cholangiocarcinoma

2018. "Liver Transplantation for Early Intrahepatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02878473.

All > Liver Transplant > Bile Duct Cancer