Radioembolization vs Microwave Ablation for Liver Cancer (REALM Trial)

N/A

Recruiting

Led By Ari Cohen, MD

Research Sponsored by Ochsner Health System

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare outcomes after 1 year of treatment for early-stage HCC to determine if 90Y lowers risk of progression. Participants will receive either 90Y or MWA, then standard care.

Who is the study for?

This trial is for adults with a new diagnosis of small, early-stage liver cancer (HCC) who also have low blood protein levels (hypoalbuminemia). They should be in good physical condition and have liver function within certain limits. People can't join if they've had previous treatments for HCC or if their tumor size exceeds 3cm.

What is being tested?

The study compares two treatments: injecting tiny radioactive beads called Therasphere 90Y into the liver's blood vessels versus using Microwave Ablation to heat and destroy the tumor. Patients will be randomly assigned to one treatment and then receive standard care.

What are the potential side effects?

Possible side effects include abdominal pain, nausea, fatigue, fever after treatment (post-embolization syndrome), changes in liver function tests, and complications from the procedures like bleeding or damage to nearby organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease Progression

Secondary study objectives

Duration of Response

Target Response Evaluation Criteria in Solid Tumors modified for HCC

Time to Retreatment

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Microwave AblationActive Control1 Intervention

Ablation performed with a high powered, gas cooled multi-antenna system targeting an ablative margin \> 5mm.

Group II: Therasphere Transarterial RadioembolizationActive Control1 Intervention

Two-phase treatment including mapping angiogram with personalized dosimetry followed by complete treatment of the tumor angiosome with 90-Yittrium glass microsphere infusion.

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