Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 74
- 主要终点
- Recurrence free survival
研究概览
简要总结
Liver transplantation is often performed to treat liver cancer, or hepatocellular carcinoma (HCC), in patients with impaired liver function due to cirrhosis. A shortcoming, however, is tumor recurrence after transplantation. Approximately 15 % of patients receiving livers develop recurrence and this depends on the quality of the liver received.
Machine liver perfusion, for example, hypothermic oxygenated liver perfusion (HOPE), which means that the organ is perfused with an oxygen-rich fluid in a cold environment before transplantation, is a novel method to improve the quality of livers before implantation. The standard of care is cold storage without perfusion.
The objective of this study is to compare the survival after tumor recurrence of patients after liver transplantation for HCC between perfused and not perfused livers. This study's hypothesis is that survival without tumor recurrence is improved when the liver is perfused before implantation.
The study involves transplant centers worldwide, and adults with HCC waiting for liver transplantation are included. 220 Patients will be recruited within 12 months and then observed for at least 2 years after transplantation. To provide the most valid results, the patients will be randomly allocated to either the organ perfusion group or a control group with standard-of-care cold storage of the organ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult recipients (>18y), listed for liver transplantation with documented HCC (Liver Imaging Reporting and Data System (LIRADS) 5 lesion in magnetic resonance imaging or computer tomography of the liver or biopsy proven),
- •within up to seven criteria, i.e. HCC with seven as the sum of the diameter of the largest tumour (in cm) and the number of tumours at the time point of liver transplantation,
- •written informed consent for the trial. This also includes patients beyond the up to seven criteria after successful downsizing of the HCC
排除标准
- •Donation after circulatory death (DCD) liver grafts
- •Combined liver transplants
- •Partial liver transplants
- •Combined or mixed hepatocellular cholangiocarcinoma (cHCC-CCC) or pure cholangiocarcinoma or other malignancies in histopathology of the liver explant
- •Systemic antitumoural medical treatment with checkpoint inhibitors or multikinase inhibitors
- •Post-transplant treatment with mTOR inhibitors
- •Acute and unexpected medical contraindications
- •Pregnancy
- •Cold storage time of > 10 hours (both study arms)
结局指标
主要结局
Recurrence free survival
时间窗: 24 months
Post transplant HCC recurrence free survival, i.e. the time interval a patient is alive without HCC recurrence after transplantation, i.e., until either HCC recurrence is observed, or the patient dies from any cause.
次要结局
- HCC recurrence (while alive)(24 months)
- HCC-related death(24 months)
- Mean number of circulating tumour deoxyribonucleic acid (DNA) in blood(6 months)
- Mean number of high-mobility-group-protein B1 (HMGB-1) in blood(1 week)
- Median Rejection Activity Index(6 months)
- Liver related complications(24 months)
- Death from any other causes than HCC(24 months)
研究者
Philipp Dutkowski
Sponsor representative and Principal Investigator
Clarunis - Universitäres Bauchzentrum Basel