Advanced Hepatocellular CarcinomaPhase 3NCT07166406
Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
A Phase 3 study testing Atezolizumab, Bevacizumab and Biospecimen Collection in people with Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, run by NRG Oncology at 139 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8
- What is being tested?
- Atezolizumab, Bevacizumab and Biospecimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 139 sitesin 2 countries
- Study dates
- 26 Feb 2026to 10 Mar 2034
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 36Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
139 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
139 sites in 2 countries
United States138 sites, 138 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Benny J. Liem
- Recruiting
Inova Alexandria Hospital
Alexandria, Virginia, 22304
Site Public Contact, 703-776-2580, Stephanie.VanBebber@inova.org
Grace Lee
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Soumon Rudra
- Recruiting
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Site Public Contact, 404-251-2854, allyson.anderson@emory.edu
Soumon Rudra
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Soumon Rudra
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Soumon Rudra
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Soumon Rudra
- Recruiting
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Site Public Contact, 800-641-2422
Lauren E. Henke
- Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Lauren E. Henke
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Mridula Krishnan
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Site Public Contact, 877-726-5130
Jennifer Y. Wo
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Parag J. Parikh
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Mark C. Korpics
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Joseph Franses
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Benjamin R. Tan
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Lauren E. Henke
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Joshua H. Petit
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Joshua H. Petit
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Eric D. Miller
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Benjamin R. Tan
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Joseph Franses
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Austin J. Iovoli
- Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Parag J. Parikh
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Parag J. Parikh
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, hemoncctrials@geisinger.edu
Austin J. Iovoli
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Manisha Palta
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Anderson A. Bauer
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Grace Lee
- Recruiting
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Grace Lee
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Grace Lee
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Joshua H. Petit
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Joshua H. Petit
- Recruiting
Palo Alto Medical Foundation-Fremont
Fremont, California, 94538
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org
Lucas Gilbride
- Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Joshua H. Petit
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Smilow Cancer Hospital-Hamden Care Center
Hamden, Connecticut, 06518
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Caressa Hui
- Recruiting
Allegiance Health
Jackson, Michigan, 49201
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Parag J. Parikh
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Baho U. Sidiqi
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Nirav S. Kapadia
- Recruiting
Inova Loudoun Hospital
Leesburg, Virginia, 20176
Site Public Contact, 703-858-6000, Keary.janet@inova.org
Grace Lee
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-374-8555, HemonCCTrials@geisinger.edu
Austin J. Iovoli
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Mark E. Bernard
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Joshua H. Petit
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Anderson A. Bauer
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
William A. Hall
- Recruiting
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org
Lauren E. Henke
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
William A. Hall
- Recruiting
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Site Public Contact, 414-805-0505
William A. Hall
- Recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Joseph Franses
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Michael H. Buckstein
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Parag J. Parikh
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
William A. Hall
- Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Site Public Contact, 262-928-7878
Timothy R. Wassenaar
- Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Site Public Contact, 402-559-5600
Mridula Krishnan
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Mridula Krishnan
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Caressa Hui
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Joseph Franses
- Recruiting
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Recruiting
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Manisha Palta
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Anderson A. Bauer
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Sutter Roseville Medical Center
Roseville, California, 95661
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Sutter Medical Center Sacramento
Sacramento, California, 95816
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Site Public Contact, 916-734-3089
Edward J. Kim
- Recruiting
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403
Site Public Contact, 415-209-2683, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Benjamin R. Tan
- Recruiting
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Benjamin R. Tan
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Benjamin R. Tan
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Benjamin R. Tan
- Recruiting
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Anderson A. Bauer
- Recruiting
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Site Public Contact, 701-364-6272
Bret E. Friday
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Byung-Han Rhieu
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Byung-Han Rhieu
- Recruiting
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Kevin L. Du
- Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-5539, Chanda.miller@phci.org
Timothy R. Wassenaar
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
William A. Hall
- Recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Parag J. Parikh
- Recruiting
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
The Iowa Clinic PC
West Des Moines, Iowa, 50266
Site Public Contact, 515-875-9815
Seema Harichand-Herdt
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Anderson A. Bauer
- Recruiting
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Austin J. Iovoli
- Recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192
Site Public Contact, nhay@hfhs.org
Parag J. Parikh
Canada1 site, 1 recruiting
- Recruiting
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca
Aruz Mesci
About this study
Official title: Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if liver SBRT in combination with IO-based systemic therapy improves survival compared to IO-based systemic therapy alone, in patients with hepatocellular cancer with macrovascular invasion.
SECONDARY OBJECTIVES:
- To evaluate and compare progression-free survival between treatment arms. II. To evaluate and compare objective response rate between treatment arms. III. To evaluate and compare vascular recanalization between treatment arms. IV. To evaluate and compare biochemical decline in alpha-fetoprotein (AFP) between treatment arms.
- To evaluate and compare toxicity within and between treatment arms. VI. To evaluate and compare liver decompensation per Child Pugh score between treatment arms.
VII. To evaluate and compare liver decompensation per modified albumin-bilirubin (ALBI) (mALBI) score between treatment arms.
HEALTH-RELATED QUALITY OF LIFE (HRQOL) OBJECTIVES:
- Primary: To compare Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score at 6 months between the treatment arms.
II. Secondary: To evaluate and compare quality-adjusted survival using European Quality of Life Five Dimension (EQ-5D) between treatment arms. (Will be done if the overall survival primary endpoint is met and/or if EQ-5D significantly differs between treatment arms.) III. Exploratory: To evaluate FACT-Hep total scores over time between the treatment arms.
EXPLORATORY OBJECTIVES:
- Biospecimen collection for future correlative analyses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive 1 of 3 IO-based systemic treatments per physician's decision.
TREATMENT A: Patients receive atezolizumab and bevacizumab intravenously (IV) every 3 weeks in the absence of disease progression or unacceptable toxicity.
TREATMENT B: Patients receive tremelimumab IV once and durvalumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
TREATMENT C: Patients receive nivolumab and ipilimumab IV every 3 weeks for up to 4 doses followed by nivolumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients receive 1 of 3 IO-based systemic treatments per physician's decision.
TREATMENT A: Patients undergo liver SBRT once daily (QD), once every other day (QOD), or twice weekly for 5 fractions over up to 3 weeks. Patients also receive atezolizumab and bevacizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
TREATMENT B: Patients undergo liver SBRT QD, QOD, or twice weekly for 5 fractions over up to 3 weeks. Patients also receive tremelimumab IV once and durvalumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
TREATMENT C: Patients undergo liver SBRT QD, QOD, or twice weekly for 5 fractions over up to 3 weeks. Patients also receive nivolumab and ipilimumab IV every 3 weeks for up to 4 doses followed by nivolumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection, chest computed tomography (CT) and CT and/or magnetic resonance imaging (MRI) throughout the study and may also undergo positron emission tomography (PET)/CT prior to registration.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years then yearly.
- Conditions
- Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8
- Being tested
- Atezolizumab, Bevacizumab, Biospecimen Collection, Computed Tomography, Durvalumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabBiological
Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A
Given IV
BevacizumabBiological
Also called ABP 215, ABP-215, ABP215, Alymsys
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT and PET/CT
DurvalumabBiological
Also called Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736
Given IV
IpilimumabBiological
Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Questionnaire AdministrationOther
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo liver SBRT
TremelimumabBiological
Also called Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP 675, CP 675206, CP-675
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (IO-based systemic therapy alone [Treatment A/B/C]) | Active comparator | Treatment A: Patients receive atezolizumab and bevacizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment B: Patients receive tremelimumab IV once and durvalumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment C: Patients receive nivolumab and ipilimumab IV every 3 weeks for up to 4 doses followed by nivolumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration. Receives: Biological: Atezolizumab; Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Biological: Tremelimumab |
| Arm 2 (SBRT + IO-based systemic therapy [Treatment A/B/C]) | Experimental | Patients undergo liver SBRT QD, QOD, or twice weekly for 5 fractions over up to 3 weeks in addition to one of the treatment regimens described below.
Treatment A: Patients receive atezolizumab and bevacizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment B: Patients receive tremelimumab IV once and durvalumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment C: Patients receive nivolumab and ipilimumab IV every 3 weeks for up to 4 doses followed by nivolumab IV every 4 weeks in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection, chest CT and CT and/or MRI throughout the study and may also undergo PET/CT prior to registration. Receives: Biological: Atezolizumab; Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Durvalumab; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy; Biological: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Will be estimated by the Kaplan-Meier method (Kaplan 1958). The distributions of the OS estimates between the two arms will be compared using a log-rank test. The Cox regression model will be used to analyze the effects of factors, in addition to treatment, including, but not limited to stratification factors, which may be associated with OS. The primary analysis will happen after at least 150 OS events (deaths) have occurred and will be tested with a 1-sided significance level of 0.022 (level based on not having stopped at either of the 2 planned interim analyses).
Measured: From the date of randomization to the date of death or last follow-up, assessed up to 5 years
Secondary outcomes (8)
Progression-free survival (PFS)
Defined as local progression, distant failure, or death due to any cause. PFS will be estimated by the Kaplan-Meier method (Kaplan 1958) and estimates between treatment arms will be compared using the log-rank test (Mantel 1966). The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, which may be associated with PFS (Cox 1972).
Measured: From the date of randomization to the date of first PFS failure or last follow-up for patients without a reported PFS event, assessed up to 5 years
Objective response rate (ORR)
Defined as having a complete or partial response. ORR will be compared between treatment arms using a chi-squared test. Duration of response will also be reported.
Measured: Up to 5 years
Vascular recanalization (VR)
Defined as having a complete or partial vascular thrombosis response. The VR proportion for each treatment arm will be determined and compared between treatment arms using a chi-squared test. Time to best VR response before progression and duration of VR response will be reported, but no statistical testing will be done.
Measured: Up to 5 years
Short-term toxicity
Defined as grade ≥ 4 adverse events (AEs). Will be compared between the treatment arms using a Z-test.
Measured: Up to 90 days from randomization
Selected long-term treatment-related toxicity
Defined as grade ≥ 4 hepatobiliary or gastrointestinal AEs and any grade 5 AE definitely related to protocol treatment. The percentage of patients with the above-specified treatment related AEs will be compared between the treatment arms using a Z-test.
Measured: Up to 18 months after randomization
Biochemical decline in alpha-fetoprotein (BD-AFP)
Failure is defined as a ≥ 20% decrease in AFP from baseline. The BD-AFP proportion for each treatment arm will be determined and compared between treatment arms using a chi-squared test.
Measured: Up to 5 years
Liver decompensation rate per Child Pugh score (LDR-CP)
Failure for this endpoint is the first occurrence of a worsening of Child Pugh score by 2 or more. The LDR-CP proportion for each treatment arm will be determined and compared between treatment arms using a chi-squared test.
Measured: Up to 5 years
Liver decompensation rate per modified albumin-bilirubin (ALBI) score (LDR-mALBI)
Failure for this endpoint is the first occurrence of a decrease in grade. The LDR-mALBI proportion for each treatment arm will be determined and compared between treatment arms using a chi-squared test.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start26 Feb 2026
- Primary completion10 Mar 2029 (estimated)
- Study completion10 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Y Wo, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166406
- Sponsor's protocol ID
- NRG-GI012
- Other IDs
- NCI-2025-05951, NRG-GI012, NRG-GI012, U10CA180868
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.