Regorafenib + Yttrium-90 for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Lynn G Feun, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lynn G Feun, MD

Principal Investigator

University of Miami

Eligibility Criteria

Adults over 18 with unresectable hepatocellular carcinoma (HCC) who haven't had systemic therapy for HCC, meet specific blood test criteria, and can safely undergo radioembolization. They must agree to contraception requirements. Excluded are those with other cancers, significant heart disease, recent bleeding events or surgeries, uncontrolled hypertension, brain metastases, or active hepatitis requiring treatment.

Inclusion Criteria

Participant agrees to comply with contraception requirements as described in protocol

Specific serum bilirubin, AST, ALT, creatinine, INR/PTT, platelet count, hemoglobin, and ANC levels within defined ranges

I have not had any drug treatments for liver cancer.

Exclusion Criteria

Previously untreated or concurrent cancer except specific exceptions

I have a wound, ulcer, or bone fracture that hasn't healed.

I do not have a serious ongoing infection.

Treatment Details

Interventions

• Regorafenib (Multi-Kinase Inhibitor)
• Yttrium-90 Radioembolization (Radiotherapy)

Trial Overview The trial is testing the combination of Regorafenib (a cancer drug) and Yttrium-90 Trans-Arterial Radioembolization (a type of targeted radiation therapy), to see how well they work together in treating patients with liver cancer that cannot be removed by surgery.

Participant Groups

Group I: Regorafenib in combination with Radioembolization Group Experimental Treatment 2 Interventions

Participants in this group will receive combination therapy of Regorafenib and Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE). Total participation duration is approximately 37 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD