RECRUITING

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma

Conditions

Unresectable Hepatocellular Carcinoma Hepatocellular Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Regorafenib and Yttrium-90 Radioembolization for Treatment of Unresectable Hepatocellular Carcinoma

Quick Facts

Study Start:2025-11-01

Study Completion:2030-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06902246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult patients ages 18 years old and above. 2. Unresectable Hepatocellular Carcinoma (HCC). 3. Child-Pugh A-B7. 4. Serum bilirubin \< 1.5 upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN. 5. Serum creatinine ≤ 1.5 x ULN. 6. 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. 7. Platelet count \> 100,000 platelets/mm3, hemoglobin (Hb) 9 g/dL, and absolute neutrophil count (ANC) 1,500 neutrophils/mm3. 8. Mapping angiogram procedure shows radioembolization is feasible and safe to perform. 9. No prior systemic therapy for HCC. 10. Participant agrees to comply with the contraception requirements as described in protocol.	1. Angiogram shows vascular shunting which prevents radioembolization. 2. Prior radioembolization. 3. Major extrahepatic disease. 4. Participants with brain metastases. 5. Participants who have not recovered from major surgery. Participants must not undergo any major surgery at or within 30 days prior to study enrollment. 6. Presence of a non-healing wound, non-healing ulcer, or bone fracture. 7. Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy. 8. Ongoing infection \> Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 9. Uncontrolled hypertension (systolic pressure \> 140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI CTCAE v5.0\] on repeated measurement) despite optimal medical management. 10. Active or clinically significant cardiac disease including: 1. Congestive heart failure - New York Heart Association (NYHA) \> Class II. 2. Active coronary artery disease. 3. Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin. 4. Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before study enrollment, or myocardial infarction within 6 months before study enrollment. 11. Evidence or history of bleeding diathesis or coagulopathy. 12. Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication. 13. 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. 14. 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. 15. Participants with impaired decision-making capacity.

Inclusion Criteria

Exclusion Criteria

1. Adult patients ages 18 years old and above.
2. Unresectable Hepatocellular Carcinoma (HCC).
3. Child-Pugh A-B7.
4. Serum bilirubin \< 1.5 upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN.
5. Serum creatinine ≤ 1.5 x ULN.
6. 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.
7. Platelet count \> 100,000 platelets/mm3, hemoglobin (Hb) 9 g/dL, and absolute neutrophil count (ANC) 1,500 neutrophils/mm3.
8. Mapping angiogram procedure shows radioembolization is feasible and safe to perform.
9. No prior systemic therapy for HCC.
10. Participant agrees to comply with the contraception requirements as described in protocol.

1. Angiogram shows vascular shunting which prevents radioembolization.
2. Prior radioembolization.
3. Major extrahepatic disease.
4. Participants with brain metastases.
5. Participants who have not recovered from major surgery. Participants must not undergo any major surgery at or within 30 days prior to study enrollment.
6. Presence of a non-healing wound, non-healing ulcer, or bone fracture.
7. Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
8. Ongoing infection \> Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
9. Uncontrolled hypertension (systolic pressure \> 140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI CTCAE v5.0\] on repeated measurement) despite optimal medical management.
10. Active or clinically significant cardiac disease including:
1. Congestive heart failure - New York Heart Association (NYHA) \> Class II.
2. Active coronary artery disease.
3. Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
4. Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before study enrollment, or myocardial infarction within 6 months before study enrollment.
11. Evidence or history of bleeding diathesis or coagulopathy.
12. Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
13. 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.
14. 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.
15. Participants with impaired decision-making capacity.

Contacts and Locations

Study Contact

Lynn G Feun, MD

CONTACT

(305) 243-4981

lfeun@med.miami.edu

Benjamin Spieler, MD

CONTACT

(305) 243-4229

bspieler@med.miami.edu

Principal Investigator

Lynn G Feun, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Lynn G Feun, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11-01

Study Completion Date2030-11-01

Study Record Updates

Study Start Date2025-11-01

Study Completion Date2030-11-01

Terms related to this study

Additional Relevant MeSH Terms

Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma