跳至主要内容
临床试验/NCT02878473
NCT02878473终止2 期

Liver Transplantation for the Treatment of Early Stages of Intrahepatic Cholangiocarcinoma in Cirrhotics

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年4月5日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
2
试验地点
2
主要终点
5 year patient survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

5 year patient survival

时间窗: 5 years

次要结局

  • disease recurrence after liver transplantation(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Liver Transplantation for Early Intrahepatic... | 临床试验