Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
Public ClinicalTrials.gov record NCT07166406. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07166406
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 226 participants
Conditions and interventions
Conditions
Interventions
- Atezolizumab Biological
- Bevacizumab Biological
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Durvalumab Biological
- Ipilimumab Biological
- Magnetic Resonance Imaging Procedure
- Nivolumab Biological
- Positron Emission Tomography Procedure
- Questionnaire Administration Other
- Stereotactic Body Radiation Therapy Radiation
- Tremelimumab Biological
Biological · Procedure · Other + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 25, 2026
- Primary completion
- Mar 9, 2029
- Completion
- Mar 9, 2034
- Last update posted
- Aug 16, 2026
2026 – 2034
United States locations
- U.S. sites
- 138
- U.S. states
- 23
- U.S. cities
- 111
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | 94704 | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | 95682 | Recruiting |
| Palo Alto Medical Foundation-Fremont | Fremont | California | 94538 | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | Recruiting |
| Palo Alto Medical Foundation-Camino Division | Mountain View | California | 94040 | Recruiting |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | Recruiting |
| Palo Alto Medical Foundation Health Care | Palo Alto | California | 94301 | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | 95661 | Recruiting |
| Sutter Roseville Medical Center | Roseville | California | 95661 | Recruiting |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | Recruiting |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | Recruiting |
| California Pacific Medical Center-Pacific Campus | San Francisco | California | 94115 | Recruiting |
| Sutter Pacific Medical Foundation | Santa Rosa | California | 95403 | Recruiting |
| Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California | 94086 | Recruiting |
| Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado | 80907 | Recruiting |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | 80909 | Recruiting |
| Memorial Hospital North | Colorado Springs | Colorado | 80920 | Recruiting |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | Recruiting |
| Cancer Care and Hematology-Fort Collins | Fort Collins | Colorado | 80528 | Recruiting |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81501 | Recruiting |
| UCHealth Greeley Hospital | Greeley | Colorado | 80631 | Recruiting |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | Recruiting |
| Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut | 06418 | Recruiting |
| Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut | 06824 | Recruiting |
| Smilow Cancer Hospital Care Center at Glastonbury | Glastonbury | Connecticut | 06033 | Recruiting |
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | 06830 | Recruiting |
| Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut | 06437 | Recruiting |
| Smilow Cancer Hospital-Hamden Care Center | Hamden | Connecticut | 06518 | Recruiting |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | Recruiting |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | Recruiting |
| Yale University | New Haven | Connecticut | 06520 | Recruiting |
| Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut | 06473 | Recruiting |
| Smilow Cancer Hospital Care Center at Long Ridge | Stamford | Connecticut | 06902 | Recruiting |
| Smilow Cancer Hospital-Torrington Care Center | Torrington | Connecticut | 06790 | Recruiting |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | Recruiting |
| Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut | 06708 | Recruiting |
| Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | 06385 | Recruiting |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | Recruiting |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | Recruiting |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | Recruiting |
| Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | 19801 | Recruiting |
| Grady Health System | Atlanta | Georgia | 30303 | Recruiting |
| Emory Proton Therapy Center | Atlanta | Georgia | 30308 | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | Recruiting |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | Recruiting |
| University of Illinois | Chicago | Illinois | 60612 | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | Recruiting |
| Carle at The Riverfront | Danville | Illinois | 61832 | Recruiting |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | Recruiting |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | Recruiting |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | Recruiting |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | Recruiting |
| Memorial Hospital East | Shiloh | Illinois | 62269 | Recruiting |
| Carle Cancer Center | Urbana | Illinois | 61801 | Recruiting |
| UChicago Medicine Northwest Indiana | Crown Point | Indiana | 46307 | Recruiting |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | Recruiting |
| Mercy Cancer Center-West Lakes | Clive | Iowa | 50325 | Recruiting |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | Recruiting |
| Greater Regional Medical Center | Creston | Iowa | 50801 | Recruiting |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | Recruiting |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | Recruiting |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | Recruiting |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | Recruiting |
| UI Health Care Mission Cancer and Blood - Waukee Clinic | Waukee | Iowa | 50263 | Recruiting |
| Mercy Medical Center-West Lakes | West Des Moines | Iowa | 50266 | Recruiting |
| The Iowa Clinic PC | West Des Moines | Iowa | 50266 | Recruiting |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | Recruiting |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | Recruiting |
| Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | 48183 | Recruiting |
| Henry Ford Medical Center-Fairlane | Dearborn | Michigan | 48126 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Allegiance Health | Jackson | Michigan | 49201 | Recruiting |
| Henry Ford Medical Center-Columbus | Novi | Michigan | 48377 | Recruiting |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | Recruiting |
| Henry Ford Wyandotte Hospital | Wyandotte | Michigan | 48192 | Recruiting |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | 56401 | Recruiting |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | Recruiting |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | Recruiting |
| Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | 55805 | Recruiting |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | Recruiting |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | Recruiting |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | Recruiting |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | Recruiting |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Recruiting |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | Recruiting |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | 68123 | Recruiting |
| Nebraska Medicine-Village Pointe | Omaha | Nebraska | 68118 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Recruiting |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | Recruiting |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | Recruiting |
| Mount Sinai Hospital | New York | New York | 10029 | Recruiting |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | Recruiting |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| Duke Cancer Center Raleigh | Raleigh | North Carolina | 27609 | Recruiting |
| UH Seidman Cancer Center at UH Avon Health Center | Avon | Ohio | 44011 | Recruiting |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | Recruiting |
| Case Western Reserve University | Cleveland | Ohio | 44106 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | 44060 | Recruiting |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | Recruiting |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | Recruiting |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Recruiting |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | Recruiting |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | Recruiting |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | Recruiting |
| Geisinger Cancer Center Dickson City | Dickson City | Pennsylvania | 18519 | Recruiting |
| Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | 17837 | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | Recruiting |
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | Recruiting |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Recruiting |
| Inova Fair Oaks Hospital | Fairfax | Virginia | 22033 | Recruiting |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Recruiting |
| Inova Loudoun Hospital | Leesburg | Virginia | 20176 | Recruiting |
| Duluth Clinic Ashland | Ashland | Wisconsin | 54806 | Recruiting |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | 54806 | Recruiting |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | Recruiting |
| Essentia Health-Hayward Clinic | Hayward | Wisconsin | 54843 | Recruiting |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | Recruiting |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
| ProHealth D N Greenwald Center | Mukwonago | Wisconsin | 53149 | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center | New Berlin | Wisconsin | 53151 | Recruiting |
| Drexel Town Square Health Center | Oak Creek | Wisconsin | 53154 | Recruiting |
| ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | Recruiting |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | Recruiting |
| Essentia Health-Spooner Clinic | Spooner | Wisconsin | 54801 | Recruiting |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | Recruiting |
| Essentia Health Saint Mary's Hospital - Superior | Superior | Wisconsin | 54880 | Recruiting |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | 53095 | Recruiting |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07166406, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 16, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07166406 live on ClinicalTrials.gov.