Embolization Techniques for Liver Cancer

Recruiting at13 trial locations

Overseen by Michael C Soulen, MD, FSIR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.

Research Team

Michael C Soulen, MD, FSIR

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Adults with biopsy-proven neuroendocrine tumors and liver metastases, who have symptoms uncontrolled by medication or progressive tumors. They must be in fairly good health (Zubrod/ECOG Performance Scale 0-2), not pregnant, and not planning other treatments during the trial. Exclusions include active infections, certain allergies to contrast media, prior hepatic artery therapy or radiation (except surgery or ablation), and severe vascular disease.

Inclusion Criteria

I am 18 years old or older.

My tumor is confirmed to be neuroendocrine through a biopsy.

I have a liver metastasis larger than 1 cm.

Exclusion Criteria

Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

I've had liver treatments but am 1 month past these and recovered from side effects.

I do not have an active infection requiring treatment.

Treatment Details

Interventions

• Bland Embolization (Procedure)
• Drug Eluting Beads Embolization (Chemotherapy)
• Transarterial chemoembolization (Chemotherapy)

Trial Overview The study is testing three types of embolization procedures on liver metastases from neuroendocrine tumors: bland embolization (BE), transarterial chemoembolization (TACE) using Lipiodol, and drug-eluting beads embolization (DEB). The goal is to compare how long each treatment can stop tumor growth in the liver without progression.

Participant Groups

Group I: Arm 3 - DEB - CLOSED Experimental Treatment 1 Intervention

Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU monthly until entire tumor burden is treated.

Group II: Arm 2 - TACE Experimental Treatment 1 Intervention

Lobar or segmental lipiodol conventional transarterial chemoembolization (TACE). Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.

Group III: Arm 1 - BE Experimental Treatment 1 Intervention

Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center of the University of Pennsylvania

Chief Executive Officer since 2017

DPhil in Immunology from Oxford University, MD from Harvard Medical School

Dr. Lawrence N. Shulman

Abramson Cancer Center of the University of Pennsylvania

Chief Medical Officer since 2017

MD from Harvard Medical School

Guerbet

Industry Sponsor

Trials

72

Recruited

94,600+

David Hale

Guerbet

Chief Executive Officer since 2020

MBA from IMD

Philippe Bourrinet

Guerbet

Chief Medical Officer since 2023

MD