Clinical trial · Interventional
Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma
A Single-Center Proof of Concept Pilot Study to Evaluate the Safety, Efficacy, and Tolerability of Sorafenib Combined With Therasphere in Subjects With Hepatocellular Carcinoma Awaiting Liver Transplantation.
NCT00846131CI-TRIAL-00023889completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A research study to determine the safety, efficacy, and tolerability of Therasphere® (also known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
| Yttrium-90 (Y-90) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Y-90 alone
- description
- Patients randomized to Arm A will proceed to Y-90 treatment alone in the Northwestern standard of care procedure
- interventionNames
- Drug: Yttrium-90 (Y-90)
- type
- EXPERIMENTAL
- label
- B: Sorafenib + Y-90
- description
- Patients randomized to Arm B will start sorafenib at a dose of 400 mg twice daily for bilirubin ≤ 1.5 x ULN and 200 mg twice daily for bilirubin \> 1.5 x ULN to ≤ 3 x ULN. After 14 days of sorafenib therapy (+/- 3 days) patients will proceed to Y-90 in the Northwestern standard of care procedure
- interventionNames
- Drug: Sorafenib
- Drug: Yttrium-90 (Y-90)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult \> 18 years olf of either gender * Diagnosis of HCC confirmed by biopsy, CT, or MRI * Able to carry out activities of daily living, awake \>50% of waking hours * Meets eligibility for liver transplantation * No prior treatment for HCC * Ability to understand and sign the informed consent * Child-bearing women and any men agree to use two forms of birth control (one of which should be a barrier method) during the course of therapy and for 8 weeks afterward. Exclusion Criteria: * Less than or = 18 years old * Ineligible for transplant due to comorbid disease * Renal Failure requiring dialysis of any kind * Severe Cardiac disease * History of a stroke * Evidence of metastatic disease- or tumors that have spread outside the liver * Known human immunodeficiency virus (HIV) infection * Uncontrolled blood pressure (systolic \> 160) despite medication(s) * Major surgery within 4 weeks prior to the screening visit * Active clinically serious infection * Serious non-healing wound, ulcer, or bone fracture. * History of gastrointestinal bleeding (GIB) within 6 weeks prior to the screening visit * Prior transplant of any kind * Must be able to swallow oral pills, tablets or capsules of any size * Use of St. John's Wort or rifampin (rifampicin). * Currently being treated with Interferon and/or Ribavirin therapy due to the thrombocytopenias, lymphopenias and anemias observed with use of these two medications. * Known or suspected allergy to sorafenib or any agent given in the course of this trial. * Any malabsorption problem * Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test 7 days prior to beginning therapy. * No potential living donor transplant (LDT-donor identified and worked up by the time of randomization into this study. If a living donor is later identified- the subject will be allowed to continue in the study. Sorafenib will be stopped at a minimum of 7 days prior to transplant surgery. * Active alcohol use, drug use, or a psychiatric disease that would, in the opinion of the PI or a subinvestigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject during their participation in the study * Inability of the potential subject to read, understand and sign the informed consent document
References
Publications (2)
- RESULTKulik L, Vouche M, Koppe S, Lewandowski RJ, Mulcahy MF, Ganger D, Habib A, Karp J, Al-Saden P, Lacouture M, Cotliar J, Abecassis M, Baker T, Salem R. Prospective randomized pilot study of Y90+/-sorafenib as bridge to transplantation in hepatocellular carcinoma. J Hepatol. 2014 Aug;61(2):309-17. doi: 10.1016/j.jhep.2014.03.023. Epub 2014 Mar 27. PMID 24681342
- RESULTVouche M, Kulik L, Atassi R, Memon K, Hickey R, Ganger D, Miller FH, Yaghmai V, Abecassis M, Baker T, Mulcahy M, Nayar R, Lewandowski RJ, Salem R. Radiological-pathological analysis of WHO, RECIST, EASL, mRECIST and DWI: Imaging analysis from a prospective randomized trial of Y90 +/- sorafenib. Hepatology. 2013 Nov;58(5):1655-66. doi: 10.1002/hep.26487. Epub 2013 Oct 1. PMID 23703789