Adding Stereotactic Body Radiation Therapy to Immunotherapy-Based Systemic Treatment for Advanced Liver Cancer (NRG-GI012, the “HELIO-RT” Study)

11/12/2025

NRG Oncology recently activated a new trial in the liver cancer space. NRG-GI012, also known as the HELIO-RT study, is a phase III randomized trial assessing whether immunotherapy-based (IO-based) systemic therapy with stereotactic body radiation therapy (SBRT) can help improve survival for patients with advanced hepatocellular cancer with macrovascular invasion, compared to IO-based systemic therapy alone. This trial is currently open for patient enrollment.

“Hepatocellular carcinoma (HCC) is the fastest-growing cause of cancer-related death in the United States. While prior studies, such as NRG-RTOG 1112, have demonstrated survival benefits with the combination of SBRT and sorafenib, outcomes remain suboptimal—highlighting the ongoing need for more effective treatment strategies in this high-risk population,” stated Jennifer Wo, MD, at Massachusetts General Hospital and the Principal Investigator of the HELIO-RT study.

The HELIO-RT trial will enroll and then stratify patients by Child Pugh score, presence of extrahepatic disease, degree of macrovascular invasion, and planned type of IO-based systemic therapy. Following stratification, patients will be randomly assigned to receive either IO-based systemic therapy alone or IO-based systemic therapy with liver SBRT.

The primary objective of this study is to determine if SBRT to the liver in combination with IO-based systemic therapy helps to improve survival for patients. Secondary aims include evaluating and comparing progression-free survival, objective response rate, vascular recanalization, biochemical decline in alpha-fetoprotein, toxicity, and liver decompensation between treatment arms.

This trial also includes health-related quality of life objectives as well as biospecimen collection for future correlative analyses.

More information:

More on NRG-GI012 can be found at ClinicalTrials.gov

Protocol documents for NRG-GI012 are available on CTSU.org.

A patient study webpage for this trial is available at NRGOncology.org/HELIO-RT