Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)
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. Secondary Objectives To evaluate and compare progression-free survival between treatment arms. To evaluate and compare objective response rate between treatment arms. To evaluate and compare vascular recanalization between treatment arms. To evaluate and compare biochemical decline in alpha-fetoprotein (AFP) between treatment arms. To evaluate and compare toxicity within and between treatment arms. To evaluate and compare liver decompensation per Child Pugh score between treatment arms. To evaluate and compare liver decompensation per modified ALBI (mALBI) score between treatment arms. Health-Related Quality-of-Life (HRQoL) Objectives Primary: To compare FACT-Hep Total Score at 6 months between the treatment arms. Secondary: To evaluate and compare Quality-Adjusted Survival using EQ-5D between treatment arms. (Will be done if the overall survival primary endpoint is met and/or if EQ-5D significantly differs between treatment arms.) Exploratory: To evaluate FACT-Hep Total Scores over time between the treatment arms. Exploratory Objectives Biospecimen collection for future correlative analyses.