Portal + Hepatic Vein Embolization for Liver Cancer

Recruiting at 55 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

Trial Summary

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 data supports the effectiveness of the treatment Portal + Hepatic Vein Embolization for Liver Cancer?

Research shows that portal vein embolization can help increase the size of the remaining liver, making liver surgery safer for patients with liver cancer. It may also improve the chances of successful surgery and potentially enhance survival rates. ^{1 2 3 4 5}

How is the treatment Portal Vein Embolization unique for liver cancer?

Portal Vein Embolization (PVE) is unique because it involves blocking part of the liver's blood supply to encourage growth in the remaining liver tissue, making it safer to remove large parts of the liver. This approach is particularly useful when the remaining liver volume is too small to support normal function after surgery. ^{1 3 6 7 8}

What is the purpose of this trial?

The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma. The main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy. Participants will: * Undergo either standard PVE or combined PVE and HVE. * Have regular imaging to assess liver resectability. * Be monitored for survival outcomes up to 5 years after intervention.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Is disease progression a contraindication for the strategy of portal vein embolization followed by hepatectomy for hepatocellular carcinoma? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy after portal vein embolization to protect against tumor growth during liver hypertrophy before hepatectomy. [2013]

3. Greece pubmed.ncbi.nlm.nih.gov

Preoperative portal vein embolization for liver malignancies. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Is preoperative portal vein embolization effective in improving prognosis after major hepatic resection in patients with advanced-stage hepatocellular carcinoma? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative portal vein embolization (PVE) for patients with hepatocellular carcinoma can improve resectability and may improve disease-free survival. [2011]

6. Greece pubmed.ncbi.nlm.nih.gov

Changes in clinicopathological findings after portal vein embolization. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Portal Vein Embolization Followed by Right-Side Hemihepatectomy for Hepatocellular Carcinoma Patients: A Japanese Multi-Institutional Study. [2018]

8. France pubmed.ncbi.nlm.nih.gov

[Portal vein embolization: Present and future]. [2021]