Liver Transplantation for Early Intrahepatic Cholangiocarcinoma
Megadott ok: Low accrual
Key facts
- Where
- Toronto, KanadaSee the site
- Phase
- 2. fázis
Where in Kanada
- University Health NetworkToronto, KanadaNo longer taking part
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT02878473
- Record updated
- 2024. december 13.
- Original description
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.Read full original descriptionShow less
Liver Transplantation for the Treatment of Early Stages of Intrahepatic Cholangiocarcinoma in Cirrhotics
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.
Inclusion: 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: 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; 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; Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min; Large vessel invasion, defined radiologically; Pregnant or breast-feeding patients.