Immunotherapy + Radiation for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase III trial compares the effect 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. Durvalumab and tremelimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). IO with monoclonal antibodies, such as 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.
Are You a Good Fit for This Trial?
This trial is for patients with advanced liver cancer, including those with up to five distinct liver tumors and a total tumor size less than 20 cm. It's open to individuals who have had their diagnosis confirmed pathologically or radiographically. Patients must not have certain rare types of liver cancer or direct tumor extension into the gastrointestinal tract, and should have relatively preserved liver function (Child-Pugh class A or B7).Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Bevacizumab
- Ipilimumab
- Nivolumab
- Stereotactic Body Radiation Therapy
- Tremelimumab
Trial Overview
The HELIO-RT Trial is comparing immunotherapy drugs alone versus in combination with Stereotactic Body Radiation Therapy (SBRT) for treating advanced hepatocellular cancer. Immunotherapies being tested include atezolizumab, bevacizumab, durvalumab, tremelimumab, nivolumab, and ipilimumab.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.