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Advanced Hepatocellular CarcinomaCancerGut healthBiologicalProcedureRadiationPhase 3

What this study is

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.

What's being tested

  • Atezolizumab

    Intervention · BIOLOGICAL

  • Bevacizumab

    Intervention · BIOLOGICAL

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT and PET/CT

  • Durvalumab

    Intervention · BIOLOGICAL

  • Ipilimumab

    Intervention · BIOLOGICAL

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Nivolumab

    Intervention · BIOLOGICAL

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET/CT

  • Questionnaire Administration

    Intervention · OTHER

    Ancillary studies

  • Stereotactic Body Radiation Therapy

    Intervention · RADIATION

    Undergo liver SBRT

  • Tremelimumab

    Intervention · BIOLOGICAL

All of Atezolizumab, Bevacizumab, Durvalumab, Ipilimumab, Nivolumab, Tremelimumab

Given IV

Study details

Official title
Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)
Sponsor
NRG Oncology
Conditions
Advanced Hepatocellular Carcinoma · Stage III Hepatocellular Carcinoma AJCC v8 · Stage IV Hepatocellular Carcinoma AJCC v8
Enrolling
226 people
Starts
2026-02-26
Est. completion
2034-03-10
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗