NCT07166406RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 3 Sept 2025
- Start date
- 26 Feb 2026
- Primary completion date
- 10 Mar 2029
- Lead sponsor
- NRG Oncology
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07166406
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 226
- From 26 Feb 2026 to the primary completion date, 10 Mar 2029
- 139 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- PRIOR TO STEP 1 REGISTRATION:
- Diagnosis of hepatocellular carcinoma (HCC) by at least 1 criterion listed below:
- Pathologically (histologically or cytologically) proven diagnosis of HCC (strongly recommended)
- Radiographically proven (American Association for the Study of Liver Diseases \[AASLD\] criteria) diagnosis of HCC by multiphasic MRI and/or CT scan is allowed.
- For patients with a prior or concurrent malignancy, pathologic confirmation of hepatocellular cancer is required.
- HCC macrovascular invasion, defined as enhancing vascular thrombosis demonstrating arterial enhancement and venous or delayed venous washout on multiphasic MRI and/or CT is required.
- Presence of extrahepatic metastatic disease on CT chest and CT or MRI pelvis, or PET/CT chest/abdomen/pelvis is permitted.
- 5 or fewer discrete intrahepatic parenchymal foci of HCC.
- Total maximal sum of hepatocellular carcinoma tumors, as a single conglomerate, multiple lesions, or infiltrative HCC \< 20 cm in total summed diameter.
- No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.
- No known fibrolamellar HCC, sarcomatoid HCC, or biphenotypic HCC.
- Child-Pugh class A or B7 liver function.
- Age ≥ 18.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Not pregnant and not nursing
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3.
- Platelets ≥ 60,000 cells/mm\^3.
- Hemoglobin ≥ 8g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8g/dl is acceptable).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 6 x institutional upper limit of normal (ULN).
- Total bilirubin \< 4 x institutional ULN.
- Creatinine clearance (CrCL) ≥ 30 mL/min/1.73 m\^2 by the Cockcroft-Gault formula.
- For treatment of HCC:
- Prior surgical resection, transarterial chemoembolization (TACE), and ablation are permitted.
- No prior systemic therapy or transarterial radioembolization (TARE) for HCC.
- No history of liver transplantation.
- For prior treatment for any malignancy:
- Prior systemic therapy for a different cancer is allowable, except for prior immunotherapy.
- No prior radiotherapy to the region of the study cancer that would result in significant overlap of radiation therapy fields that would lead to excessive cumulative toxicity at the discretion of the investigator.
- No medical contraindication to the standard of care immunotherapy.
- For patients to be treated with atezolizumab/bevacizumab:
- No history of a gastrointestinal (GI) bleed or other clinically significant bleeding event within 6 months prior to study registration.
- Systemic immunostimulatory agents (including, but not limited to, interferons and interleukin-2 \[IL-2\]) are prohibited within 4 weeks or five drug elimination half-lives (whichever is longer) prior to registration and during the study period.
- No history of allergic reaction to the systemic therapy agent(s), compounds of similar chemical or biologic composition to the systemic therapy agent(s) (or any of its excipients).
- PRIOR TO STEP 2 RANDOMIZATION:
- Obtain confirmation of payment coverage (insurance or other) for both possible treatment arms.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (139)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network, Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Inova Alexandria Hospital Coordinator of this site? Confirm its status | Alexandria | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Coordinator of this site? Confirm its status | Ankeny | United States | Recruiting |
| Duluth Clinic Ashland Coordinator of this site? Confirm its status | Ashland | United States | Recruiting |
| Northwest Wisconsin Cancer Center Coordinator of this site? Confirm its status | Ashland | United States | Recruiting |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Proton Therapy Center Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| UH Seidman Cancer Center at UH Avon Health Center Coordinator of this site? Confirm its status | Avon | United States | Recruiting |
| UHHS-Chagrin Highlands Medical Center Coordinator of this site? Confirm its status | Beachwood | United States | Recruiting |
| Nebraska Medicine-Bellevue Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Alta Bates Summit Medical Center-Herrick Campus Coordinator of this site? Confirm its status | Berkeley | United States | Recruiting |
| Massachusetts General Hospital Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Essentia Health Saint Joseph's Medical Center Coordinator of this site? Confirm its status | Brainerd | United States | Recruiting |
| Henry Ford Cancer Institute-Downriver Coordinator of this site? Confirm its status | Brownstown | United States | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park Coordinator of this site? Confirm its status | Cameron Park | United States | Recruiting |
| Christiana Care Health System-Concord Health Center Coordinator of this site? Confirm its status | Chadds Ford | United States | Recruiting |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital Coordinator of this site? Confirm its status | City of Saint Peters | United States | Recruiting |
| Clackamas Radiation Oncology Center Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Mercy Cancer Center-West Lakes Coordinator of this site? Confirm its status | Clive | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Coordinator of this site? Confirm its status | Clive | United States | Recruiting |
| Rocky Mountain Cancer Centers-Penrose Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Memorial Hospital North Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| UCHealth Memorial Hospital Central Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Greater Regional Medical Center Coordinator of this site? Confirm its status | Creston | United States | Recruiting |
| Siteman Cancer Center at West County Hospital Coordinator of this site? Confirm its status | Creve Coeur | United States | Recruiting |
| UChicago Medicine Northwest Indiana Coordinator of this site? Confirm its status | Crown Point | United States | Recruiting |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Henry Ford Medical Center-Fairlane Coordinator of this site? Confirm its status | Dearborn | United States | Recruiting |
| Essentia Health - Deer River Clinic Coordinator of this site? Confirm its status | Deer River | United States | Recruiting |
| Smilow Cancer Hospital-Derby Care Center Coordinator of this site? Confirm its status | Derby | United States | Recruiting |
| Mercy Medical Center - Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Iowa Methodist Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Geisinger Cancer Center Dickson City Coordinator of this site? Confirm its status | Dickson City | United States | Recruiting |
| Essentia Health Cancer Center Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Essentia Health Saint Mary's Medical Center Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Miller-Dwan Hospital Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Recruiting |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Recruiting |
| Inova Fair Oaks Hospital Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Inova Schar Cancer Institute Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Smilow Cancer Hospital Care Center-Fairfield Coordinator of this site? Confirm its status | Fairfield | United States | Recruiting |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Falls Church | United States | Recruiting |
| Cancer Care and Hematology-Fort Collins Coordinator of this site? Confirm its status | Fort Collins | United States | Recruiting |
| Poudre Valley Hospital Coordinator of this site? Confirm its status | Fort Collins | United States | Recruiting |
| Palo Alto Medical Foundation-Fremont Coordinator of this site? Confirm its status | Fremont | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Glastonbury Coordinator of this site? Confirm its status | Glastonbury | United States | Recruiting |
| Saint Mary's Hospital and Regional Medical Center Coordinator of this site? Confirm its status | Grand Junction | United States | Recruiting |
| UCHealth Greeley Hospital Coordinator of this site? Confirm its status | Greeley | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Greenwich Coordinator of this site? Confirm its status | Greenwich | United States | Recruiting |
| Smilow Cancer Hospital Care Center - Guilford Coordinator of this site? Confirm its status | Guilford | United States | Recruiting |
| Smilow Cancer Hospital-Hamden Care Center Coordinator of this site? Confirm its status | Hamden | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Saint Francis Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| Essentia Health-Hayward Clinic Coordinator of this site? Confirm its status | Hayward | United States | Recruiting |
| Essentia Health Hibbing Clinic Coordinator of this site? Confirm its status | Hibbing | United States | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Allegiance Health Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Northwell Health/Center for Advanced Medicine Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| Inova Loudoun Hospital Coordinator of this site? Confirm its status | Leesburg | United States | Recruiting |
| Geisinger Medical Oncology-Lewisburg Coordinator of this site? Confirm its status | Lewisburg | United States | Recruiting |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Medical Center of the Rockies Coordinator of this site? Confirm its status | Loveland | United States | Recruiting |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Recruiting |
| Froedtert Menomonee Falls Hospital Coordinator of this site? Confirm its status | Menomonee Falls | United States | Recruiting |
| UH Seidman Cancer Center at Lake Health Mentor Campus Coordinator of this site? Confirm its status | Mentor | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Palo Alto Medical Foundation-Camino Division Coordinator of this site? Confirm its status | Mountain View | United States | Recruiting |
| ProHealth D N Greenwald Center Coordinator of this site? Confirm its status | Mukwonago | United States | Recruiting |
| Medical Oncology Hematology Consultants PA Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Christiana Care Health System-Christiana Hospital Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Providence Newberg Medical Center Coordinator of this site? Confirm its status | Newberg | United States | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center Coordinator of this site? Confirm its status | New Berlin | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Smilow Cancer Center/Yale-New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| UC Comprehensive Cancer Center at Silver Cross Coordinator of this site? Confirm its status | New Lenox | United States | Recruiting |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Yale-New Haven Hospital North Haven Medical Center Coordinator of this site? Confirm its status | North Haven | United States | Recruiting |
| Henry Ford Medical Center-Columbus Coordinator of this site? Confirm its status | Novi | United States | Recruiting |
| Drexel Town Square Health Center Coordinator of this site? Confirm its status | Oak Creek | United States | Recruiting |
| ProHealth Oconomowoc Memorial Hospital Coordinator of this site? Confirm its status | Oconomowoc | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Nebraska Medicine-Village Pointe Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Providence Willamette Falls Medical Center Coordinator of this site? Confirm its status | Oregon City | United States | Recruiting |
| University of Chicago Medicine-Orland Park Coordinator of this site? Confirm its status | Orland Park | United States | Recruiting |
| Palo Alto Medical Foundation Health Care Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Duke Cancer Center Raleigh Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Roseville Coordinator of this site? Confirm its status | Roseville | United States | Recruiting |
| Sutter Roseville Medical Center Coordinator of this site? Confirm its status | Roseville | United States | Recruiting |
| Sutter Medical Center Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Essentia Health Sandstone Coordinator of this site? Confirm its status | Sandstone | United States | Recruiting |
| California Pacific Medical Center-Pacific Campus Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Sutter Pacific Medical Foundation Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Memorial Hospital East Coordinator of this site? Confirm its status | Shiloh | United States | Recruiting |
| Essentia Health-Spooner Clinic Coordinator of this site? Confirm its status | Spooner | United States | Recruiting |
| Smilow Cancer Hospital Care Center at Long Ridge Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| Marshfield Medical Center-River Region at Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Recruiting |
| Siteman Cancer Center at Christian Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Palo Alto Medical Foundation-Sunnyvale Coordinator of this site? Confirm its status | Sunnyvale | United States | Recruiting |
| Essentia Health Saint Mary's Hospital - Superior Coordinator of this site? Confirm its status | Superior | United States | Recruiting |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Smilow Cancer Hospital-Torrington Care Center Coordinator of this site? Confirm its status | Torrington | United States | Recruiting |
| Smilow Cancer Hospital Care Center-Trumbull Coordinator of this site? Confirm its status | Trumbull | United States | Recruiting |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| Essentia Health Virginia Clinic Coordinator of this site? Confirm its status | Virginia | United States | Recruiting |
| Smilow Cancer Hospital-Waterbury Care Center Coordinator of this site? Confirm its status | Waterbury | United States | Recruiting |
| Smilow Cancer Hospital Care Center - Waterford Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Coordinator of this site? Confirm its status | Waukee | United States | Recruiting |
| UW Cancer Center at ProHealth Care Coordinator of this site? Confirm its status | Waukesha | United States | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center Coordinator of this site? Confirm its status | West Bend | United States | Recruiting |
| Henry Ford West Bloomfield Hospital Coordinator of this site? Confirm its status | West Bloomfield | United States | Recruiting |
| The Iowa Clinic PC Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
| Mercy Medical Center-West Lakes Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Recruiting |
| Christiana Care Health System-Wilmington Hospital Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
| Henry Ford Wyandotte Hospital Coordinator of this site? Confirm its status | Wyandotte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.