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Unresectable Hepatocellular CarcinomaPhase 2NCT06902246

Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma

A Phase 2 study testing Regorafenib and TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization in people with Unresectable Hepatocellular Carcinoma and Hepatocellular Carcinoma, run by University of Miami.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Regorafenib and TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Aug 2031
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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.

Being tested
Regorafenib, TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegorafenibDrug

    Also called Stivarga

    Participants will orally self-administer Regorafenib tablets for the first 21 days of each 28-day cycle as follows. Dose-escalation will occur only if there are no significant drug-related adverse events:

    • Safety Run-in Phase: For the first six (6) participants enrolled. The starting dose is 80 mg/day during Cycles 1 and 2. In Cycle 3, the starting dose is 80 mg/day on Days 1 to 7, escalating to 120 mg/day on Days 8 to 14, and then escalating to a maximum dose of 160 mg/day on Days 15 to 21. Participants will continue to receive the maximum tolerated dose determined at the end of Cycle 3.
    • Phase 2: For participants enrolled after the Safety Run-in phase. In Cycle 1, the starting dose is 80 mg/day on Days 1 to 7, escalating to 120 mg/day on Days 8 to 14, and then escalating to a maximum dose 160 mg/day on Days 15 to 21. From Cycle 2 onward, participants will take 160 mg/day (or maximum tolerated dose from Cycle 1), on Days 1 to 21.

  • TheraSphere™ Yttrium-90 Trans-Arterial RadioembolizationRadiation

    Also called Y-90 TARE

    Y-90 absorbed glass microspheres will be administered standard of care once via the percutaneous trans-arterial approach after the first 3 weeks of Regorafenib treatment but before Day 28. Additional Y-90 absorbed glass microsphere administration is allowed for treatment of baseline disease in the absence of disease progression within 6 months of the initial Y-90 TARE treatment.

Study groups in NCT06902246
Study groupRoleWhat they receive
Regorafenib in combination with Radioembolization GroupExperimentalParticipants in this group will receive combination therapy of Regorafenib and Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE). Participants will receive therapy until unacceptable toxicity, disease progression, or withdrawal of consent, whichever occurs first. Total participation duration is approximately 37 months.
Receives: Drug: Regorafenib; Radiation: TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Control Rate (DCR) Measured by Number of Participants

    Disease Control Rate (DCR) is defined as the number of participants experiencing a best response of complete response (CR), partial response (PR), or stable disease (SD) after receiving protocol therapy. Response will be assessed using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria for hepatocellular carcinoma.

    Measured: Up to 24 months

  2. Number of Participants Experiencing Treatment Related Adverse Events

    The number of participants experiencing treatment-related adverse events (AEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

    Measured: Up to 25 months

  3. Number of Participants Experiencing Treatment Related Serious Adverse Events

    The number of participants experiencing treatment-related serious adverse events (SAEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

    Measured: Up to 25 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Objective response rate (ORR) is the proportion of patients achieving complete response (CR) or partial response (PR) as the best response. Response will be assessed using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria for hepatocellular carcinoma.

    Measured: Up to 36 months

  2. Time to Tumor Progression

    Time-to-tumor progression is defined as the period of time in months from start date of study treatment until documented date of confirmed disease progression. For participants without progression, follow-up time will be censored at the date of last disease assessment (as per mRECIST).

    Measured: Up to 36 months

  3. Duration of Overall Response (DOR)

    The duration of overall response (DOR) is measured in months from the time measurement criteria are met for complete response (CR) or partial response (PR) per mRECIST criteria, until the first date that recurrent or progressive disease is documented. For participants without progression, follow-up time will be censored at the date of last disease assessment, per mRECIST criteria.

    Measured: Up to 36 months

  4. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the elapsed time in months from the first date of study treatment until documented disease progression, per mRECIST criteria or death from any cause, whichever is earlier. For participants who remain alive without progression, follow-up time will be censored at the date of last disease assessment, per mRECIST criteria.

    Measured: Up to 36 months

  5. Overall Survival (OS)

    Overall survival (OS) is defined as the elapsed time in months from date of first study treatment until death from any cause. Participants without documented death will be censored at the last date known to be alive.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Aug 2031 (estimated)
  4. Study completion1 Aug 2031 (estimated)

Why it stopped: Investigator decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06902246
Sponsor's protocol ID
20230806
Status last verified
Jun 2026
First submitted
24 Mar 2025
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib and TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization in people with Unresectable Hepatocellular Carcinoma and Hepatocellular Carcinoma, run by University of Miami.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) Measured by Number of Participants (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06902246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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