At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Hypothermic oxygenated perfusion (procedure), Conventional cold storage (procedure)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- Hypothermic oxygenated perfusion — procedure: All study centres will use either VitaSmart, Liver assist or Perlife devices for machine liver perfusion, with a pressure controlled hypothermic oxygenated liver perfusion through the portal vein (HOPE) or through the portal vein and the hepatic artery (DHOPE), targeting a flow rate between 200-250 ml/min at a pressure of 3 mmHg, and a perfusate temperature between 8-12°C. · Conventional cold storage — procedure: Conventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called HOPE, looks at cancer outcomes after liver transplantation in people with liver cancer (hepatocellular carcinoma, or HCC). It includes adults whose cancer is within the 'up to seven' criteria, meaning the size of the largest tumour added to the number of tumours is seven or less. The sponsor is Philipp Dutkowski.
Who can take part
- Adults over 18 listed for a liver transplant
- HCC shown by scans (MRI or CT) or confirmed by biopsy
- Cancer within the 'up to seven' rule: the largest tumour's size in cm plus the number of tumours adds up to seven or fewer
- This also includes people who first went beyond the rule but whose tumours shrank with treatment
- Written informed consent to take part
Who may not be able to
- Livers donated after circulatory death
- Combined transplants with another organ
- Partial liver transplants
- Certain other cancer types found in the removed liver, including mixed or pure cholangiocarcinoma
- Anti-cancer drug treatment with checkpoint inhibitors or multikinase inhibitors
- Treatment after transplant with mTOR inhibitors (a type of medicine)
- Sudden or urgent medical reasons that make taking part unsafe
- Pregnancy
- Cold storage time of the donated liver over 10 hours
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 220
- Started
- 2025-08-01
- Last checked
- 2025-12
Plain English Summary
What is this study?
- • Testing a new treatment for liver transplantation
- • Phase4 - 220 participants
- • Liver transplantation is often performed to treat liver cancer, or hepatocellular carcinoma (HCC), in patients with impaired liver function due to cirrhosis
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with liver transplantation
Where?
- • Birmingham - University Hospitals Birmingham
- • Leeds - Leeds Teaching Hospitals NHS Trust
- • London - The Royal Free Hospital (London)
- • London - King's College Hospital (London)
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓within up to seven criteria, i.e. HCC with seven as the sum of the diameter of the largest tumour (in cm) and the...
- ✓written agreement to take part for the trial. This also includes patients beyond the up to seven criteria after successful...
Who cannot take part
- ✗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...
- ✗Systemic antitumoural medical treatment with checkpoint inhibitors or multikinase inhibitors
See the full criteria
Where Is This Study? (5 UK sites)
University Hospitals Birmingham
Birmingham B15 2GW, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds LS97TF, United Kingdom
The Royal Free Hospital (London)
London NW3 2QG, United Kingdom
King's College Hospital (London)
London SE5 9RS, United Kingdom
Freeman Hospital (Newcastle)
Newcastle NE7 7DN, United Kingdom
How to Get in Touch
Philipp Dutkowski, Professor
Sponsor contactCONTACT