Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: III
Principal Investigator: Krishnan, Mridula
Contact Information:
Erin Drengler
edrengler@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07166406?term=NCT07166406&rank=1#participation-criteria
Summary
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 compare toxicity within and between treatment arms. VI. To evaluate and compare liver decompensation per Child Pugh score between treatment arms.
VII. To evaluate and compare liver decompensation per modified albumin-bilirubin (ALBI) (mALBI) score between treatment arms.
HEALTH-RELATED QUALITY OF LIFE (HRQOL) OBJECTIVES:
I. To compare Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score at 6 months between the treatment arms. (Primary)
II. To evaluate and compare quality-adjusted survival using European Quality of Life Five Dimension (EQ-5D) between treatment arms. (Secondary)
III. To evaluate FACT-Hep total scores over time between the treatment arms. (Exploratory)
EXPLORATORY OBJECTIVES:
I. Biospecimen collection for future correlative analyses.