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Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
NCT06902246Phase 2
Key facts
- Status
- Withdrawn
- Start
- Aug 2026
- Primary completion
- Aug 2031
- Sponsor
- University of Miami
- Modality
- Small Molecules
- Drugs
- regorafenib
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of regorafenib in hepatocellular carcinoma (HCC), sponsored by University of Miami. Primary endpoints: Disease Control Rate at 24 months, Number of Participants Experiencing Treatment Related Adverse Events at 25 months and 1 more. Planned start Aug 2026; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Regorafenib in combination with Radioembolization Group
Participants receive combination therapy of Regorafenib and Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE).
03
Who it enrols
Adults with unresectable hepatocellular carcinoma, Child-Pugh A-B7, adequate organ function, no prior systemic therapy for HCC or prior radioembolization, and no major extrahepatic disease or brain metastases.
04
Endpoints
Primary
Disease Control Rate
Number of Participants Experiencing Treatment Related Adverse Events
Number of Participants Experiencing Treatment Related Serious Adverse Events
Secondary
Objective Response Rate
Time to Tumor Progression
Duration of Overall Response
Progression-Free Survival
Overall Survival
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