Hypothermic Oxygenated Perfusion for Liver Cancer

(HOPE4Cancer Trial)

Recruiting at 39 trial locations

Overseen By Philipp Dutkowski, Professor

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Philipp Dutkowski

Must not be taking: Checkpoint inhibitors, Multikinase inhibitors, mTOR inhibitors

Disqualifiers: Pregnancy, Other malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for preparing livers for transplantation in individuals with liver cancer, specifically hepatocellular carcinoma (HCC). The researchers aim to determine if hypothermic oxygenated perfusion (HOPE), which involves soaking the liver in oxygen-rich fluid while cold, helps prevent cancer recurrence after a transplant. Participants will receive either a liver treated with this new method or one stored using conventional cold storage. This trial targets adults awaiting a liver transplant due to HCC, with specific tumor size and number criteria. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain cancer treatments like checkpoint inhibitors or multikinase inhibitors.

What is the safety track record for hypothermic oxygenated perfusion?

Research has shown that hypothermic oxygenated perfusion (HOPE) is generally well-tolerated. Studies have found that livers treated with HOPE before transplantation have a low risk of failure, meaning they usually function well post-transplantation.

Additionally, the long-term results are encouraging. Recipients of livers treated with HOPE have shown excellent survival rates over five years. This suggests that HOPE is a safe method for preparing livers for transplantation.

Since this trial is in a later phase, the treatment has already demonstrated a strong safety record in earlier studies. This should reassure potential participants about the treatment's safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about hypothermic oxygenated perfusion (HOPE) for liver cancer because it offers a refreshing twist on preserving donor livers. Unlike standard methods like conventional cold storage, HOPE uses a machine to circulate oxygen-rich, cold perfusate through the liver, keeping it healthier and potentially improving transplant outcomes. This method targets the liver's blood vessels directly, maintaining a steady flow and optimal temperature that may enhance liver function after transplantation. By potentially reducing the risk of organ damage during storage, HOPE could lead to better recovery and longer-lasting transplants for patients.

What evidence suggests that hypothermic oxygenated perfusion is effective for liver cancer?

This trial will compare hypothermic oxygenated perfusion (HOPE) with conventional cold storage for liver transplants. Studies have shown that HOPE can enhance liver transplant success by reducing complications and improving early liver function, leading to better survival rates. Research indicates that patients with livers treated with HOPE experience excellent long-term survival, with fewer instances of liver rejection or failure. Additionally, HOPE is linked to a lower risk of serious liver problems post-transplant. These findings suggest that HOPE could improve survival rates for liver cancer patients undergoing transplants, without cancer recurrence. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with liver cancer (HCC) who are listed for a liver transplant. They must have a specific type of tumor or biopsy-proven HCC and agree to the study's terms. It includes those initially beyond certain criteria but whose tumors were downsized successfully.

Inclusion Criteria

I have given my written consent to participate in the trial.

I am an adult listed for a liver transplant due to confirmed liver cancer.

My liver cancer involves a tumor or tumors with a combined size and number not exceeding seven.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo liver transplantation with either hypothermic oxygenated perfusion or conventional cold storage

Immediate

1 visit (in-person)

Initial Follow-up

Participants are monitored for early post-transplant outcomes, including circulating tumor DNA and HMGB-1 levels

6 months

Multiple visits (in-person)

Extended Follow-up

Participants are monitored for recurrence-free survival and liver-related complications

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Cold Storage
• Hypothermic Oxygenated Perfusion

Trial Overview The trial compares two methods before liver transplantation: hypothermic oxygenated perfusion (HOPE), where the organ is treated with cold, oxygen-rich fluid, versus conventional cold storage without perfusion. The goal is to see if HOPE improves survival without cancer recurrence.

How Is the Trial Designed?

Group I: Hypothermic oxygenated perfusion Experimental Treatment 1 Intervention

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. The perfusate consists of 3L re-circulating Belzer MPS® (Bridge to Life Ltd.) with an active oxygenation (70-110 kPa). The minimum perfusion duration is defined at 2 hours, while perfusion is generally continued until the recipient hepatectomy is completed. The perfusion will exclusively be performed in the recipient centre after initial cold storage and bench preparation of the liver for implantation. The perfusion devices are routinely used in all participating centres (VitaSmart, Bridge to Life®, Liver Assist, XVIVO®, Perlife, Aferitica®).

Group II: Conventional cold storage Active Control 1 Intervention

Conventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care. For cold storage at the Swiss centres, IGL-1 (Institute George Lopez) is used for cold storage. Liver transplant centres in other European countries, use mainly three other storage solutions (Histidine trypophan-ketoglutarat, HTK and University of Wisconsin, UW solution, Celsior) in accordance to their national guidelines.

Who Is Running the Clinical Trial?

Philipp Dutkowski

Lead Sponsor

Trials

1

Recruited

220+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465341/

Hypothermic oxygenated perfusion (HOPE) against cancer ... For example, machine liver perfusion reduces post-transplant complications and increases graft survival by improving early allograft function [ ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0168827824023419

Long-term outcomes after hypothermic oxygenated ... This study shows excellent 5-year survival after transplantation of HOPE-treated DBD and DCD livers with low rates of graft loss due to PNF or IC, irrespective ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06717919

NCT06717919 | HOPE Against Cancer Recurrence in HCC Approximately 15 % of patients receiving livers develop recurrence and this depends on the quality of the liver received. Machine liver perfusion, for example, ...

4. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2025/11000/long_term_follow_up_after_hypothermic_oxygenated.7.aspx

Long-term Follow-up After Hypothermic Oxygenated ... Moreover, the short-term outcome data of this trial suggested a 2-fold reduction in the incidence of acute cellular rejection (ACR) after DHOPE, compared with ...

5. journal-of-hepatology.eu journal-of-hepatology.eu/article/S0168-8278(23)00012-0/fulltext

A multicenter randomized-controlled trial of hypothermic ... Exploratory findings suggest that HOPE decreases the risk of severe liver graft-related events. Impact and implications. This randomized controlled phase III ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41013675/

Hypothermic oxygenated perfusion (HOPE) against cancer ... Hypothermic oxygenated perfusion (HOPE) is a novel machine liver perfusion approach to optimize liver grafts before implantation and has been ...