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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

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 25, 2016
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE April 5, 2018
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
5 year patient survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02878473 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
disease recurrence after liver transplantation [ Time Frame: 5 years ]
5-years cumulative risk of recurrence after LT.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liver Transplantation for Early Intrahepatic Cholangiocarcinoma
Official Title  ICMJE Liver Transplantation for the Treatment of Early Stages of Intrahepatic Cholangiocarcinoma in Cirrhotics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intrahepatic Cholangiocarcinoma
Intervention  ICMJE Procedure: Deceased donor Liver Transplantation
Deceased donor orthotopic liver transplantation
Study Arms  ICMJE Experimental: Liver transplantation
The intervention will consist of liver transplantation
Intervention: Procedure: Deceased donor Liver Transplantation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2029
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Erin Winter, BSC 416-340-4800 ext 6093 erin.winter@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02878473
Other Study ID Numbers  ICMJE 16-9999
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gonzalo Sapisochin, MD University Health Network, Toronto
Principal Investigator: Jordi Bruix, MD Hospital Clinic of Barcelona
PRS Account University Health Network, Toronto
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP