Actively Recruiting
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
Led by University of Miami · Updated on 2026-05-01
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients ages 18 years old and above
- Unresectable Hepatocellular Carcinoma (HCC)
- Child-Pugh A-B7 liver function
- Serum bilirubin less than 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 5 times ULN
- Serum creatinine less than or equal to 1.5 times ULN
- INR/PTT less than or equal to 1.5 times ULN, including those on prophylactic anticoagulation without abnormal coagulation history
- Platelet count greater than 100,000 platelets/mm3
- Hemoglobin at least 9 g/dL
- Absolute neutrophil count at least 1,500 neutrophils/mm3
- Mapping angiogram shows radioembolization is feasible and safe
- No prior systemic therapy for HCC
- Agreement to comply with contraception requirements as described in the protocol
You will not qualify if you...
- Angiogram shows vascular shunting that prevents radioembolization
- Prior radioembolization treatment
- Major extrahepatic disease
- Presence of brain metastases
- Not recovered from major surgery or surgery within 30 days prior to enrollment
- Presence of non-healing wound, non-healing ulcer, or bone fracture
- Known HIV infection or active hepatitis B or C requiring antiviral treatment
- Ongoing infection greater than Grade 2 per NCI CTCAE v5.0
- Uncontrolled hypertension despite optimal medical therapy
- Active or significant cardiac disease including congestive heart failure NYHA Class III or higher, active coronary artery disease, arrhythmias needing certain anti-arrhythmic drugs, unstable angina, recent myocardial infarction
- History or evidence of bleeding disorders or coagulopathy
- Recent severe bleeding event (Grade 3 or higher) within 4 weeks prior to study medication
- Thrombotic or embolic events within 6 months before treatment or consent
- Presence of untreated or concurrent cancers distinct from HCC except certain treated cancers; all other cancers must be disease-free for over 3 years
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
L
Lynn G Feun, MD
CONTACT
B
Benjamin Spieler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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