New combo therapy aims to control inoperable liver cancer
NCT ID NCT06902246
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining the drug regorafenib with a targeted radiation treatment (Y-90 radioembolization) can control liver cancer that cannot be removed by surgery. About 30 adults with this type of liver cancer will receive the combination therapy. The main goals are to see how many patients have their disease controlled or shrink, and to monitor any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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