This phase II trial tests the safety and side effects of regorafenib in combination with yttrium-90 (Y-90) transarterial radioembolization (TARE) and how well the combination works in treating patients with hepatocellular cancer (HCC) that cannot be removed by surgery (unresectable). Regorafenib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Regorafenib is a type of kinase inhibitor and a type of antiangiogenesis agent. Radioactive drugs, such as Y-90, may carry radiation directly to tumor cells and not harm normal cells. Radioembolization, a type of radiation therapy, uses tiny beads that hold the Y-90. The beads are injected into the hepatic artery (the main blood vessel that carries blood to the liver). The beads collect in the tumor and the Y 90 gives off radiation. This destroys the blood vessels that the tumor needs to grow and kills the tumor cells. The radioactivity emitted may also activate the immune system to find and attack other tumor cells in the body. Giving regorafenib in combination with Y-90 TARE may be safe, tolerable, and/or effective in treating patients with unresectable HCC.
Additional locations may be listed on ClinicalTrials.gov for NCT06902246.
Locations matching your search criteria
United States
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Lynn G. Feun
Phone: 305-321-3473
PRIMARY OBJECTIVE:
I. To assess the efficacy and toxicity of regorafenib followed by Y-90 TARE in patients with unresectable HCC.
SECONDARY OBJECTIVE:
I. To assess objective response rate (ORR), time-to-tumor progression, duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
EXPLORATORY OBJECTIVES:
I. To assess participant-reported disease and treatment-related symptoms and health-related quality of life (HRQoL) in participants with unresectable HCC amenable to locoregional therapy.
II. To assess downstaging following TARE + regorafenib in participants with unresectable HCC amenable to locoregional therapy.
III. To investigate peripheral and tumor biomarkers that may correlate with study intervention or likelihood of treatment response and disease control rate.
IV. To describe tumor and normal tissue absorbed radioembolization dose and its relationship with response and outcomes and liver volume changes after treatment.
OUTLINE:
Patients receive regorafenib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 28 days for up to 24 months (2 years) in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 24 months may continue to receive regorafenib at the discretion of the investigator. Starting between day 22 and day 27 of cycle 1, patients receive Y-90 via TARE. Patients may receive an additional Y-90 TARE treatment within 6 months of initial treatment in the absence of disease progression. Additionally, patients undergo blood sample collection, mapping angiography, magnetic resonance imaging (MRI), computed tomography (CT), Y-90 single photon emission computed tomography (SPECT)/CT, and technetium Tc-99m macroaggregated albumin (99m^Tc-MAA) SPECT/CT throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 12 months (1 year).
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorLynn G. Feun