Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
NCT ID: NCT07166406
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
252 participants
INTERVENTIONAL
2025-10-07
2029-03-10
Brief Summary
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Detailed Description
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I. 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:
I. 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.
V. 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:
I. To compare Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score at 6 months between the treatment arms. (Primary) II. To evaluate and compare quality-adjusted survival using European Quality of Life Five Dimension (EQ-5D) between treatment arms. (Secondary) III. To evaluate FACT-Hep total scores over time between the treatment arms. (Exploratory)
EXPLORATORY OBJECTIVES:
I. 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 physicians 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 physicians 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 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 treatment A (atezolizumab, bevacizumab)
Patients receive atezolizumab and bevacizumab IV every 3 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.
Atezolizumab
Given IV
Bevacizumab
Given IV
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Arm 1 treatment B (tremelimumab, durvalumab)
Patients receive tremelimumab IV once and durvalumab 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.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Tremelimumab
Given IV
Durvalumab
Given IV
Arm 1 treatment C (nivolumab, ipilimumab)
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.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Nivolumab
Given IV
Ipilimumab
Given IV
Arm 2 treatment A (atezolizumab, bevacizumab, SBRT)
Arm 2 treatment A (atezolizumab, bevacizumab, SBRT) Patients undergo liver SBRT QD, 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. 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.
Atezolizumab
Given IV
Bevacizumab
Given IV
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Positron Emission Tomography
Undergo PET/CT
Arm 2 treatment B (tremelimumab, durvalumab, SBRT)
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. 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.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Tremelimumab
Given IV
Durvalumab
Given IV
Stereotactic Body Radiation Therapy
Undergo liver SBRT
Arm 2 treatment C (nivolumab, ipilimumab, SBRT)
Patients undergo liver SBRT QD, QOD, or twice weekly for 5 fractions over up to 3 weeks. 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.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Nivolumab
Given IV
Ipilimumab
Given IV
Stereotactic Body Radiation Therapy
Undergo liver SBRT
Interventions
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Atezolizumab
Given IV
Bevacizumab
Given IV
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Tremelimumab
Given IV
Durvalumab
Given IV
Nivolumab
Given IV
Ipilimumab
Given IV
Stereotactic Body Radiation Therapy
Undergo liver SBRT
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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NRG Oncology
OTHER
Responsible Party
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Locations
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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
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
Saint Mary's Hospital and Regional Medical Center
Grand Junction, 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
Memorial Hospital East
Shiloh, Illinois, 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 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
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 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
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
Essentia Health-Hayward Clinic
Hayward, Wisconsin, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, United States
Countries
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Facility Contacts
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Other Identifiers
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NCI-2025-05951
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-GI012
Identifier Type: -
Identifier Source: org_study_id
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