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Procedure

Embolization Techniques for Liver Cancer

Phase 2

Waitlist Available

Led By Michael C Soulen, MD, FSIR

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants 18 years and older

Biopsy-proven neuroendocrine tumor

Must not have

Active infection (Symptomatic bacterial and fungal infection - newly diagnosed and/or requiring treatment)

Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether chemoembolization is more effective than bland embolization for treating liver cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include abdominal pain, fever, nausea, infection at the catheter site, allergic reactions to materials used during procedures like contrast dye for imaging tests. There's also a risk of liver damage due to blocking blood flow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My tumor is confirmed to be neuroendocrine through a biopsy.

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I have a liver metastasis larger than 1 cm.

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I am not planning to receive any other treatments besides the trial, except for medications for hormone regulation or bone strength.

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I can take care of myself but might not be able to do heavy physical work.

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Most of my cancer is in the liver, but it takes up 70% or less of my liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active infection requiring treatment.

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I have had surgery or a procedure to improve bile flow from my liver.

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I cannot have IV contrast due to a severe past reaction.

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I do not have specific liver blood flow issues or brain conditions related to liver disease.

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I cannot undergo certain blood vessel imaging due to severe allergies, bleeding issues, or severe blood vessel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abdominal MRI/Triple Phase CT

Secondary study objectives

Number of Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3 - DEB - CLOSEDExperimental Treatment1 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 - TACEExperimental Treatment1 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 - BEExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transarterial chemoembolization

2019

Completed Phase 3

~1230

0 / 11Eligibility criteria met