Portal + Hepatic Vein Embolization for Liver Cancer

Recruiting at 60 trial locations

Overseen By Sinead James, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Maastricht University

Disqualifiers: Liver cirrhosis, Portal hypertension, Cholangitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

358 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining two procedures, portal vein embolization (PVE) and hepatic vein embolization (HVE), can make more liver cancer patients eligible for surgery and extend their lives. It targets those with specific liver cancers, such as hepatocellular carcinoma or cholangiocarcinoma, who are not yet surgical candidates. Participants will receive either PVE alone or both PVE and HVE, with regular check-ups to assess surgical eligibility and track survival over five years. Suitable candidates have been diagnosed with these specific liver cancers and have reduced liver function requiring PVE. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations that might improve surgical eligibility and survival outcomes.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this protocol is safe for liver cancer patients?

Research has shown that combining portal vein embolization (PVE) and hepatic vein embolization (HVE) is generally safe for patients. Studies have found that this combination does not result in procedure-related deaths. Many patients have successfully undergone liver surgery after this combined treatment, suggesting it makes surgery more feasible.

For PVE alone, research suggests it can be safely performed in patients with hepatocellular carcinoma, a type of liver cancer. It has been linked to better survival rates after major liver surgeries.

Overall, both PVE alone and the combined PVE/HVE are considered safe and well-tolerated, with no serious safety issues reported in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach combining Portal and Hepatic Vein Embolization (PVE/HVE) for liver cancer because it offers a unique way to enhance liver regeneration before surgery. Unlike the standard treatment of Portal Vein Embolization (PVE) alone, which focuses solely on blocking blood flow to part of the liver to encourage growth in the remaining sections, the combined method also targets the hepatic veins. This dual approach may boost the liver's ability to regenerate faster and more effectively, potentially improving surgical outcomes and expanding treatment options for patients who were previously ineligible for surgery.

What evidence suggests that this trial's treatments could be effective for liver cancer?

In this trial, participants will be assigned to one of two treatment arms. The control arm will receive portal vein embolization (PVE) alone, while the interventional arm will receive a combination of portal vein embolization and hepatic vein embolization (PVE/HVE). Research has shown that combining these two procedures may lead to better outcomes for liver cancer patients. Studies have found that this combined method allows for more successful liver surgeries, where cancerous parts are removed, compared to using PVE alone. Specifically, one study reported a 95.2% success rate for surgeries with the combined treatment, versus 76.5% with just PVE. This approach also promotes liver growth, making surgery easier. Additionally, there are encouraging signs of better long-term survival rates. Overall, evidence suggests that adding HVE to PVE could significantly benefit liver cancer patients. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

The DRAGON-PLC trial is for patients with initially unresectable primary liver cancer, specifically hepatocellular carcinoma and cholangiocarcinoma. Participants must meet certain health standards to be eligible.

Inclusion Criteria

I understand the trial details and can give my consent.

I have been diagnosed with a type of primary liver cancer.

I need a procedure to increase my liver volume because it's too small or not working well.

Exclusion Criteria

Unable to understand the study information, study instructions and give informed consent

Pregnant women

I am premenopausal and cannot or will not use long-term birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either standard PVE or combined PVE and HVE to improve liver resectability

3 weeks

Regular imaging visits to assess liver resectability

Follow-up

Participants are monitored for survival outcomes and liver function after intervention

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hepatic Vein Embolization
• Portal Vein Embolization

Trial Overview This study tests if combining portal vein embolization (PVE) with hepatic vein embolization (HVE) can make more liver cancers removable by surgery and improve survival over 5 years compared to PVE alone.

How Is the Trial Designed?

Group I: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - Interventional arm Experimental Treatment 2 Interventions

Combined Portal and Hepatic Vein Embolization (PVE/HVE)

Group II: Portal Vein Embolization (PVE) - control arm Active Control 1 Intervention

Portal Vein Embolization (PVE) alone

Who Is Running the Clinical Trial?

Maastricht University

Lead Sponsor

Trials

246

Recruited

13,190,000+

Citations

1. tandfonline.com tandfonline.com/doi/full/10.2217/hep-2021-0006

Full article: Portal vein embolization: rationale, techniques, ... The procedure achieves 5-year overall survival of 45.3% compared with 12.5% in patients who underwent PVE before surgery [Citation57]. Despite undergoing portal ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ags3.70085

Efficacy of Sequential Hepatic Vein Embolization Following ... This study determined that sequential PVE–HVE is a safe procedure that improves the efficacy of liver regeneration before major hepatectomy ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40902881/

Simultaneous Portal and Hepatic Vein Embolization versus ... Resection rates were higher in the PHVE group (95.2% vs. 76.5%, P = .008), with fewer tumor progressions during follow-up (3.2% vs. 14.7%, P = .

4. sciencedirect.com sciencedirect.com/science/article/pii/S1051044325005743

Simultaneous Portal and Hepatic Vein Embolization versus ... Simultaneous portal and hepatic vein embolization (PHVE) achieved significantly higher FLR absolute hypertrophy (FLRabh), degree of hypertrophy ...

5. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(25)00076-6/fulltext

Safety and efficacy of combined portal and hepatic vein ... Current evidence is promising, suggesting PVE/HVE may surpass PVE alone in terms future liver remnant hypertrophy, resection rates, and even long-term survival.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666776225000766

Safety and efficacy of combined portal and hepatic vein ... This prospective multinational study demonstrates that PVE/HVE is safe, without embolization-related mortality, and results in a high resection rate in patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3760463/

Portal Vein Embolization for Hepatocellular Carcinoma Recent clinical results have suggested that PVE can be safely performed in patients with HCC and that it contributes to improved survival after major ...