Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06902246
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Regorafenib — DRUG
    Participants will orally self-administer Regorafenib tablets for the first 21 days of each 28-day cycle as follows. Dose-escalation will occur only if there are no significant drug-related adverse events: * Safety Run-in Phase: For the first six (6) participants enrolled. The starting dose is 80 mg/day during Cycles 1 and 2. In Cycle 3, the starting dose is 80 mg/day on Days 1 to 7, escalating to 120 mg/day on Days 8 to 14, and then escalating to a maximum dose of 160 mg/day on Days 15 to 21. Participants will continue to receive the maximum tolerated dose determined at the end of Cycle 3. * Phase 2: For participants enrolled after the Safety Run-in phase. In Cycle 1, the starting dose is 80 mg/day on Days 1 to 7, escalating to 120 mg/day on Days 8 to 14, and then escalating to a maximum dose 160 mg/day on Days 15 to 21. From Cycle 2 onward, participants will take 160 mg/day (or maximum tolerated dose from Cycle 1), on Days 1 to 21.
  • TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization — RADIATION
    Y-90 absorbed glass microspheres will be administered standard of care once via the percutaneous trans-arterial approach after the first 3 weeks of Regorafenib treatment but before Day 28. Additional Y-90 absorbed glass microsphere administration is allowed for treatment of baseline disease in the absence of disease progression within 6 months of the initial Y-90 TARE treatment.

Study Details

The purpose of this study is to determine the effects that Regorafenib in combination with Yttrium-90 (Y-90) radioembolization has on patients with unresectable hepatocellular carcinoma.

Key Dates

Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2031
Completion
Aug 1, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Regorafenib in combination with Radioembolization Group
    Participants in this group will receive combination therapy of Regorafenib and Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE). Participants will receive therapy until unacceptable toxicity, disease progression, or withdrawal of consent, whichever occurs first. Total participation duration is approximately 37 months.

Primary Outcome Measure

Disease Control Rate (DCR) Measured by Number of Participants [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Lynn G Feun, MD
[email protected]
(305) 243-4981
Benjamin Spieler, MD
[email protected]
(305) 243-4229
Lynn G Feun, MD (PRINCIPAL_INVESTIGATOR)
Benjamin Spieler, MD (PRINCIPAL_INVESTIGATOR)

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