Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)
NRG Oncology
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.
Description
PRIMARY OBJECTIVE: 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 demonstr…
Interventions
- BiologicalAtezolizumab
Given IV
- BiologicalBevacizumab
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT and PET/CT
- BiologicalDurvalumab
Given IV
- BiologicalIpilimumab
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Locations (107)
- Alta Bates Summit Medical Center-Herrick CampusBerkeley, California
- Sutter Cancer Centers Radiation Oncology Services-Cameron ParkCameron Park, California
- Palo Alto Medical Foundation-FremontFremont, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- Palo Alto Medical Foundation-Camino DivisionMountain View, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California