Status:
RECRUITING
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Bayer
Conditions:
Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Adult patients ages 18 years old and above.
- Unresectable Hepatocellular Carcinoma (HCC).
- Child-Pugh A-B7.
- Serum bilirubin \< 1.5 upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN.
- Serum creatinine ≤ 1.5 x ULN.
- International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 x ULN. Note: Participants who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists.
- Platelet count \> 100,000 platelets/mm3, hemoglobin (Hb) 9 g/dL, and absolute neutrophil count (ANC) 1,500 neutrophils/mm3.
- Mapping angiogram procedure shows radioembolization is feasible and safe to perform.
- No prior systemic therapy for HCC.
- Participant agrees to comply with the contraception requirements as described in protocol.
Exclusion
- Angiogram shows vascular shunting which prevents radioembolization.
- Prior radioembolization.
- Major extrahepatic disease.
- Participants with brain metastases.
- Participants who have not recovered from major surgery. Participants must not undergo any major surgery at or within 30 days prior to study enrollment.
- Presence of a non-healing wound, non-healing ulcer, or bone fracture.
- Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
- Ongoing infection \> Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Uncontrolled hypertension (systolic pressure \> 140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI CTCAE v5.0\] on repeated measurement) despite optimal medical management.
- Active or clinically significant cardiac disease including:
- Congestive heart failure - New York Heart Association (NYHA) \> Class II.
- Active coronary artery disease.
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before study enrollment, or myocardial infarction within 6 months before study enrollment.
- Evidence or history of bleeding diathesis or coagulopathy.
- Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
- Participants with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment or within 6 months of informed consent.
- Participants with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor. Participants surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed. All cancer treatments must be completed at least 3 years prior to registration.
- Participants with impaired decision-making capacity.
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 5 2031
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06902246
Start Date
January 5 2026
End Date
January 5 2031
Last Update
December 2 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136