Liver Transplantation for Early Intrahepatic Cholangiocarcinoma (LT for iCCA)

University Health Network, Toronto

Status and phase

Terminated

Phase 2

Conditions

Intrahepatic Cholangiocarcinoma

Treatments

Procedure: Deceased donor Liver Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02878473

17-5306

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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