Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Atezolizumab: Given IV
Bevacizumab: Given IV
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT and PET/CT
Durvalumab: Given IV
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
Positron Emission Tomography: Undergo PET/CT
Questionnaire Administration: Ancillary studies
Stereotactic Body Radiation Therapy: Undergo liver SBRT
Tremelimumab: Given IV
Study 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). 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.
Eligibility
Primary outcome measure(s)
- Overall survival (OS) — From the date of randomization to the date of death or last follow-up, assessed up to 5 years
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).
Trial sites (139)
| Facility | City | Region | Status |
|---|---|---|---|
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | Recruiting |
| Palo Alto Medical Foundation-Fremont | Fremont | California | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | Recruiting |
| Palo Alto Medical Foundation-Camino Division | Mountain View | California | Recruiting |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | Recruiting |
| Palo Alto Medical Foundation Health Care | Palo Alto | California | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | Recruiting |
| Sutter Roseville Medical Center | Roseville | California | Recruiting |
| Sutter Medical Center Sacramento | Sacramento | California | Recruiting |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | Recruiting |
| California Pacific Medical Center-Pacific Campus | San Francisco | California | Recruiting |
| Sutter Pacific Medical Foundation | Santa Rosa | California | Recruiting |
| Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California | Recruiting |
| Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado | Recruiting |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | Recruiting |
| Memorial Hospital North | Colorado Springs | Colorado | Recruiting |
| Poudre Valley Hospital | Fort Collins | Colorado | Recruiting |
| Cancer Care and Hematology-Fort Collins | Fort Collins | Colorado | Recruiting |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | Recruiting |
| UCHealth Greeley Hospital | Greeley | Colorado | Recruiting |
| Medical Center of the Rockies | Loveland | Colorado | Recruiting |
| Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center at Glastonbury | Glastonbury | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center at Greenwich | Greenwich | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut | Recruiting |
| Smilow Cancer Hospital-Hamden Care Center | Hamden | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | Recruiting |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | Recruiting |
| Yale University | New Haven | Connecticut | Recruiting |
| Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center at Long Ridge | Stamford | Connecticut | Recruiting |
| Smilow Cancer Hospital-Torrington Care Center | Torrington | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | Recruiting |
| Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut | Recruiting |
| Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut | Recruiting |
| Helen F Graham Cancer Center | Newark | Delaware | Recruiting |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | Recruiting |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | Recruiting |
+ 99 more sites — see the full list on the official registry below.
On this site
📄 Tecentriq (atezolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile → 📄 Imfinzi (durvalumab) drug profile → 📄 Opdivo (nivolumab) drug profile →More NRG Oncology trials in Canada
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07166406 on ClinicalTrials.gov ↗ ← All trials in Canada