Actively Recruiting
Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
Led by NRG Oncology · Updated on 2026-05-04
226
Participants Needed
107
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma by pathology or radiographic criteria
- Presence of hepatocellular cancer with macrovascular invasion confirmed by imaging
- Allowed extrahepatic metastatic disease
- Five or fewer liver tumor spots
- Total liver tumor size less than 20 cm
- No direct tumor spread into stomach or intestines
- No fibrolamellar, sarcomatoid, or biphenotypic hepatocellular cancer
- Child-Pugh class A or B7 liver function
- Age 18 years or older
- ECOG performance status 0-2
- Not pregnant or nursing with negative pregnancy test if applicable
- Absolute neutrophil count at least 1,500 cells/mm^3
- Platelet count at least 60,000 cells/mm^3
- Hemoglobin at least 8 g/dl (transfusions allowed to meet this)
- AST and ALT no more than 6 times upper limit of normal
- Total bilirubin less than 4 times upper limit of normal
- Creatinine clearance at least 30 mL/min/1.73 m^2
- Prior liver surgery, chemoembolization, or ablation allowed
- No prior systemic therapy or radioembolization for hepatocellular cancer
- No history of liver transplant
- Prior systemic therapy for other cancers allowed except prior immunotherapy
- No prior radiation overlapping study area causing excess toxicity
- No medical contraindication to immunotherapy
- For atezolizumab/bevacizumab treatment, no significant GI bleeding within 6 months
- No recent use of systemic immunostimulatory agents within 4 weeks before registration
- No history of allergic reaction to study immunotherapy agents
- Insurance coverage confirmed before randomization
You will not qualify if you...
- Known fibrolamellar, sarcomatoid, or biphenotypic hepatocellular cancer
- History of liver transplantation
- Prior systemic immunotherapy for hepatocellular cancer
- Prior radiation therapy overlapping study area with risk of excess toxicity
- Significant gastrointestinal bleeding event within 6 months for atezolizumab/bevacizumab candidates
- Medical contraindication to standard immunotherapy
- Recent use of systemic immunostimulatory agents such as interferons or interleukin-2 within 4 weeks before registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 107 locations
1
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Actively Recruiting
2
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Actively Recruiting
3
Palo Alto Medical Foundation-Fremont
Fremont, California, United States, 94538
Actively Recruiting
4
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
5
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Actively Recruiting
6
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
7
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Actively Recruiting
8
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
Actively Recruiting
9
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Actively Recruiting
10
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
Actively Recruiting
11
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
12
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94115
Actively Recruiting
13
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
14
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States, 94086
Actively Recruiting
15
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Actively Recruiting
16
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States, 80528
Actively Recruiting
17
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81501
Actively Recruiting
18
UCHealth Greeley Hospital
Greeley, Colorado, United States, 80631
Actively Recruiting
19
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
20
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
21
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States, 06824
Actively Recruiting
22
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States, 06033
Actively Recruiting
23
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States, 06830
Actively Recruiting
24
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
25
Smilow Cancer Hospital-Hamden Care Center
Hamden, Connecticut, United States, 06518
Actively Recruiting
26
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
27
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
28
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
29
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Actively Recruiting
30
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States, 06902
Actively Recruiting
31
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States, 06790
Actively Recruiting
32
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
33
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States, 06708
Actively Recruiting
34
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
35
Grady Health System
Atlanta, Georgia, United States, 30303
Actively Recruiting
36
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
Actively Recruiting
37
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
38
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
39
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
40
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
41
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
42
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
43
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
44
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States, 46307
Actively Recruiting
45
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
46
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Actively Recruiting
47
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
48
Greater Regional Medical Center
Creston, Iowa, United States, 50801
Actively Recruiting
49
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
50
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
51
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
52
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
53
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
54
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Actively Recruiting
55
The Iowa Clinic PC
West Des Moines, Iowa, United States, 50266
Actively Recruiting
56
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
57
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States, 48183
Actively Recruiting
58
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Actively Recruiting
59
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
60
Allegiance Health
Jackson, Michigan, United States, 49201
Actively Recruiting
61
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
Actively Recruiting
62
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
63
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States, 48192
Actively Recruiting
64
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
65
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
66
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
67
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
68
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Actively Recruiting
69
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
70
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
71
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
72
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
73
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
74
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
75
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
76
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
77
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
78
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
79
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
80
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
81
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
82
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Actively Recruiting
83
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
84
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
85
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
86
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
87
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
88
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Actively Recruiting
89
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
90
Inova Alexandria Hospital
Alexandria, Virginia, United States, 22304
Actively Recruiting
91
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
92
Inova Fair Oaks Hospital
Fairfax, Virginia, United States, 22033
Actively Recruiting
93
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
94
Inova Loudoun Hospital
Leesburg, Virginia, United States, 20176
Actively Recruiting
95
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
96
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, United States, 54806
Actively Recruiting
97
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
98
Essentia Health-Hayward Clinic
Hayward, Wisconsin, United States, 54843
Actively Recruiting
99
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
100
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Actively Recruiting
101
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Actively Recruiting
102
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
103
Essentia Health-Spooner Clinic
Spooner, Wisconsin, United States, 54801
Actively Recruiting
104
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
105
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, United States, 54880
Actively Recruiting
106
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
107
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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