NRG-GI012

Open to Accrual

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Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer with Macrovascular Invasion (HELIO-RT)

Status

Open to Accrual

Date Opened To Accrual

October 7, 2025


Disease Site

Gastrointestinal [GI] Liver

Phase

III

Developmental Therapeutics

No

Primary Objective

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.

Patient Population

Diagnosis of hepatocellular cancer (HCC).  HCC
macrovascular invasion, defined as enhancing vascular thrombosis demonstrating
arterial enhancement and venous or delayed venous washout on multiphasic MRI
and/or CT.

Target Accrual

226

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.