RecruitingPhase 3NCT07166406

Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)


Sponsor

NRG Oncology

Enrollment

226 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase III trial compares the effect of immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. IO with monoclonal antibodies, such as durvalumab, tremelimumab, atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (HELIO-RT) is studying whether adding targeted radiation therapy (stereotactic body radiation therapy, or SBRT) to immunotherapy improves outcomes in people with advanced liver cancer (hepatocellular carcinoma, or HCC) that has invaded nearby blood vessels or spread to other organs. Immunotherapy alone is currently standard; this trial tests whether radiation can boost that effect. **You may be eligible if...** - You have been diagnosed with hepatocellular carcinoma (liver cancer), confirmed by biopsy or special imaging - Your cancer has spread into major liver blood vessels (macrovascular invasion) and/or has spread to other parts of the body - You have not yet received systemic treatment for advanced liver cancer - Your liver function is adequate **You may NOT be eligible if...** - You have already received immunotherapy or systemic treatment for liver cancer - Your liver function is severely impaired - You have active autoimmune disease - You have had a liver or other organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given IV

BIOLOGICALBevacizumab

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT and PET/CT

BIOLOGICALDurvalumab

Given IV

BIOLOGICALIpilimumab

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNivolumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONStereotactic Body Radiation Therapy

Undergo liver SBRT

BIOLOGICALTremelimumab

Given IV


Locations(107)

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Smilow Cancer Hospital-Hamden Care Center

Hamden, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Grady Health System

Atlanta, Georgia, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Greater Regional Medical Center

Creston, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

The Iowa Clinic PC

West Des Moines, Iowa, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Miller-Dwan Hospital

Duluth, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Mount Sinai Hospital

New York, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Inova Alexandria Hospital

Alexandria, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Inova Fair Oaks Hospital

Fairfax, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Inova Loudoun Hospital

Leesburg, Virginia, United States

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Essentia Health-Hayward Clinic

Hayward, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Essentia Health-Spooner Clinic

Spooner, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

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NCT07166406


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