Clinical trial NCT06717919: HOPE Against Cancer Recurrence in HCC
Official title: Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Liver Transplantation
HCC
Oncological Outcomes
Keywords: HOPE
randomised controlled trial
multicentre
hepatocellular carcinoma
liver transplantation
Lead sponsor: Clarunis - Universitäres Bauchzentrum Basel
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Recurrence free survival
timeFrame: 24 months
Secondary outcomes:
measure: HCC recurrence (while alive)
timeFrame: 24 months
measure: HCC recurrence (while alive)
timeFrame: 24 months
measure: HCC-related death
timeFrame: 24 months
measure: HCC-related death
timeFrame: 24 months
measure: Death from any other causes than HCC
timeFrame: 24 months
measure: Death from any other causes than HCC
timeFrame: 24 months
measure: Mean number of circulating tumour deoxyribonucleic acid (DNA) in blood
timeFrame: 6 months
measure: Mean number of high-mobility-group-protein B1 (HMGB-1) in blood
timeFrame: 1 week
measure: Median Rejection Activity Index
timeFrame: 6 months
measure: Liver related complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
References: