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Liver Transplantation for Early Intrahepatic Cholangiocarcinoma (LT for iCCA)

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ClinicalTrials.gov Identifier: NCT02878473
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Procedure: Deceased donor Liver Transplantation Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liver Transplantation for the Treatment of Early Stages of Intrahepatic Cholangiocarcinoma in Cirrhotics
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2029


Arm Intervention/treatment
Experimental: Liver transplantation
The intervention will consist of liver transplantation
Procedure: Deceased donor Liver Transplantation
Deceased donor orthotopic liver transplantation




Primary Outcome Measures :
  1. 5 year patient survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. disease recurrence after liver transplantation [ Time Frame: 5 years ]
    5-years cumulative risk of recurrence after LT.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878473


Contacts
Contact: Erin Winter, BSC 416-340-4800 ext 6093 erin.winter@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Erin Winter, BSc    416-340-4800 ext 6093    erin.winter@uhn.ca   
Principal Investigator: Gonzalo Sapisochin, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Gonzalo Sapisochin, MD University Health Network, Toronto
Principal Investigator: Jordi Bruix, MD Hospital Clinic of Barcelona

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02878473     History of Changes
Other Study ID Numbers: 16-9999
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Extracts
Hematinics