Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma (NCT06902246) | Clinical Trial Compass
RecruitingPhase 2
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
United States30 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Mapping angiogram procedure shows radioembolization is feasible and safe to perform.
Exclusion criteria
✕. 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.
What they're measuring
1
Disease Control Rate (DCR) Measured by Number of Participants
Timeframe: Up to 24 months
2
Number of Participants Experiencing Treatment Related Adverse Events
Timeframe: Up to 25 months
3
Number of Participants Experiencing Treatment Related Serious Adverse Events
✕. 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.