Liver Transplantation for Early Intrahepatic Cholangiocarcinoma (LT for iCCA)
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Deceased donor Liver Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group: 0 or 1 at all times prior to Liver Transplantation
- Absence of cancer-related symptoms
- Liver cirrhosis (any etiology)
- Patient not eligible for liver resection due to poor liver function/portal hypertension
- Biopsy proven "very early" intrahepatic cholangiocarcinoma (iCCA)
- Willing and able to provide written informed consent.
- Negative serum pregnancy test for women of childbearing potential
- Biopsy proven "very early" (single ≤2 cm) iCCa
- No vascular or biliary involvement seen in preoperative imaging
- No extra-hepatic disease seen in preoperative imaging
- Carbohydrate Antigen (CA) 19.9 values are ≤100 ng/mL
Exclusion Criteria:
- Previous or concurrent cancer (with some exceptions)
- Patients that have had previous liver resection for iCCA and the current tumor is a recurrence.
- Progression of the tumor in size >3 cm or development of extrahepatic disease.
- Large vessel invasion, defined radiologically.
- Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
- Pulmonary insufficiency
- History of cardiac disease:
- Uncontrolled infection(s)
- Known history of human immunodeficiency virus (HIV) infection.
- History of solid organ transplantation
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liver transplantation
Arm Description
The intervention will consist of liver transplantation
Outcomes
Primary Outcome Measures
5 year patient survival
Secondary Outcome Measures
disease recurrence after liver transplantation
5-years cumulative risk of recurrence after LT.
Full Information
NCT ID
NCT02878473
First Posted
August 17, 2016
Last Updated
July 24, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02878473
Brief Title
Liver Transplantation for Early Intrahepatic Cholangiocarcinoma
Acronym
LT for iCCA
Official Title
Liver Transplantation for the Treatment of Early Stages of Intrahepatic Cholangiocarcinoma in Cirrhotics
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres due to historically poor results. Two retrospective evaluations have shown a 5 year survival ~65% in selected patients with an iCCA diagnosis at the pathology of the explanted liver. This suggests that LT can be a curative treatment if applied selectively. This study will evaluate the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients who meet the strict selection criteria. Patients with advanced cirrhosis (not candidates for resection) currently have no other curative treatment options. Participants will be allowed bridging therapies prior to receiving transplant. Participants will be followed for 5 years from the time of transplant with patient survival and disease recurrence as outcome measures.
Detailed Description
Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with liver cirrhosis. iCCA is not an indication for Liver transplantation (LT) at most transplant centres given the historically poor rates of survival and high rates of disease recurrence. A recent retrospective study shows that patients found to have very early iCCA on explant after undergoing LT for another indication, had a 5 year survival of 65% and recurrence rate of 13%.This suggests that LT can be a curative treatment if applied selectively and that it is time to reevaluate LT as a treatment option for those with very early iCCA. This study will evaluate the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients. Diagnosis of iCCA will be based upon biopsy results of a new tumor which does not present radiologically as an HCC. Patients fulfilling the strict study selection criteria will undergo a full transplant assessment and must be deemed otherwise "suitable" for liver transplant as per their centre's criteria. Patients will be treated with bridging therapies while they are on the transplant waiting list according to each center's policy. Patients with disease progression (tumor >3cm or development of extrahepatic disease) at any time prior to transplantation will be excluded. Participants will be followed for 5 years from the time of transplant with patient survival and disease recurrence as outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liver transplantation
Arm Type
Experimental
Arm Description
The intervention will consist of liver transplantation
Intervention Type
Procedure
Intervention Name(s)
Deceased donor Liver Transplantation
Intervention Description
Deceased donor orthotopic liver transplantation
Primary Outcome Measure Information:
Title
5 year patient survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
disease recurrence after liver transplantation
Description
5-years cumulative risk of recurrence after LT.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group: 0 or 1 at all times prior to Liver Transplantation
Absence of cancer-related symptoms
Liver cirrhosis (any etiology)
Patient not eligible for liver resection due to poor liver function/portal hypertension
Biopsy proven "very early" intrahepatic cholangiocarcinoma (iCCA)
Willing and able to provide written informed consent.
Negative serum pregnancy test for women of childbearing potential
Biopsy proven "very early" (single ≤2 cm) iCCa
No vascular or biliary involvement seen in preoperative imaging
No extra-hepatic disease seen in preoperative imaging
Carbohydrate Antigen (CA) 19.9 values are ≤100 ng/mL
Exclusion Criteria:
Previous or concurrent cancer (with some exceptions)
Patients that have had previous liver resection for iCCA and the current tumor is a recurrence.
Progression of the tumor in size >3 cm or development of extrahepatic disease.
Large vessel invasion, defined radiologically.
Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
Pulmonary insufficiency
History of cardiac disease:
Uncontrolled infection(s)
Known history of human immunodeficiency virus (HIV) infection.
History of solid organ transplantation
Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Pregnant or breast-feeding patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Winter, BSC
Phone
416-340-4800
Ext
6093
Email
erin.winter@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo Sapisochin, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jordi Bruix, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Winter, BSc
Phone
416-340-4800
Ext
6093
Email
erin.winter@uhn.ca
First Name & Middle Initial & Last Name & Degree
Gonzalo Sapisochin, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27481548
Citation
Sapisochin G, Facciuto M, Rubbia-Brandt L, Marti J, Mehta N, Yao FY, Vibert E, Cherqui D, Grant DR, Hernandez-Alejandro R, Dale CH, Cucchetti A, Pinna A, Hwang S, Lee SG, Agopian VG, Busuttil RW, Rizvi S, Heimbach JK, Montenovo M, Reyes J, Cesaretti M, Soubrane O, Reichman T, Seal J, Kim PT, Klintmalm G, Sposito C, Mazzaferro V, Dutkowski P, Clavien PA, Toso C, Majno P, Kneteman N, Saunders C, Bruix J; iCCA International Consortium. Liver transplantation for "very early" intrahepatic cholangiocarcinoma: International retrospective study supporting a prospective assessment. Hepatology. 2016 Oct;64(4):1178-88. doi: 10.1002/hep.28744. Epub 2016 Aug 24.
Results Reference
background
Learn more about this trial
Liver Transplantation for Early Intrahepatic Cholangiocarcinoma
We'll reach out to this number within 24 hrs