- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00846131
Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma
13. September 2016 aktualisiert von: Laura Kulik, Northwestern University
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.
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Because Hepatocellular carcinoma (HCC) grows by forming new blood vessels liver transplant (OLT) offers the best chance for long term survival.
However, with the growing number of patients who require OLT, prolonged wait list times often lead to drop out from the transplant list due to tumor progression.
Some patients are granted an "upgrade",within the generally accepted guidelines for transplant eligibility, in order to expedite the access of patients with early HCC to transplantation before tumor progression.
The use of therapies like radioembolization also known as Yttrium-90 ([Y-90] a procedure where very small beads coated with radiation are injected directly into the tumor through an artery in your groin) while awaiting OLT has become common at most transplant centers, including Northwestern, to help patients reach transplant.
Additionally, these treatments are being used to move patients to a status eligible for transplant.
We are studying whether a combination approach with systemic therapy and therapy applied directly to the liver, will be more successful than a single therapy .
Angiogenesis (a process involving the growth of new blood vessels from pre-existing vessels) plays an important role in the early stages of HCC.
A decrease in angiogenesis both locally within the treated tumor as well as in any existing tumor cells, not yet detected, would hopefully decrease the incidence of post transplant recurrence of HCC.
All subjects enrolled in this study will be treated with the use of Therasphere, Y-90, which is composed of nonbiodegradable glass microspheres coated with the radioactive compound Y-90 which are injected into the hepatic artery.
The concentrated radioactive microspheres within the tumor lead to "inside-out" radiation.
Half of the subjects will be treated with sorafenib (NEXAVAR®) in conjunction with Y-90.
The determination of which subjects will receive sorafenib will be made randomly, like the flip of a coin.
Sorafenib works by slowing the growth of the tumor cell , attacking the tumor from the outside.
Researchers hope to determine whether the subjects treated with sorafenib have an overall improved response to liver directed therapy with Y-90 Therasphere.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
24
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Northwestern Memorial Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: A: Y-90 alone
Patients randomized to Arm A will proceed to Y-90 treatment alone in the Northwestern standard of care procedure
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Patients undergo radioembolization with Yttrium 90 microspheres by hepatic artery infusion
Andere Namen:
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Experimental: B: Sorafenib + Y-90
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
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Patients undergo radioembolization with Yttrium 90 microspheres by hepatic artery infusion
Andere Namen:
Randomized to Y-90 ± Sorafenib
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
To Evaluate sorafenib as an adjunct to Y-90 for control of HCC as a bridge/downstage to transplant
Zeitfenster: Up to one year
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Subjects randomized to receive Sorafenib take the drug for 2 weeks before treatment with Y90.
They have imaging (CT/MRI) 2 weeks after starting Sorafenib then are treated.
Post-treatment patients have blood drawn and adverse event evaluation at 2 weeks, 4 weeks, 6 weeks, and then every 6 weeks up to 1 year or time of transplant.
Repeat imaging is done at 4 weeks, and then every 3 months post-treatment.
Subjects not receiving Sorafenib are treated with Y90 and then are evaluated post-treatment the same as the subjects that receive the drug.
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Up to one year
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
To characterize the toxicity profile of sorafenib and Y90 using NCI CTC toxicity grading scales.
Zeitfenster: up to 1 year
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Subjects randomized to receive Sorafenib take the drug for 2 weeks before treatment with Y90.
They have imaging (CT/MRI) 2 weeks after starting Sorafenib then are treated.
Post-treatment patients have blood drawn and adverse event evaluation at 2 weeks, 4 weeks, 6 weeks, and then every 6 weeks up to 1 year or time of transplant.
Repeat imaging is done at 4 weeks, and then every 3 months post-treatment.
Subjects not receiving Sorafenib are treated with Y90 and then are evaluated post-treatment the same as the subjects that receive the drug.
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up to 1 year
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To identify predictive and prognostic markers of how the liver cancer will respond to treatment.
Zeitfenster: up to 1 year
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All subjects are evaluated with lab work and adverse event assessment at 2, 4, and 6 weeks post-treatment, and then every 6 weeks up to 1 year or when they receive transplant.
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up to 1 year
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Laura Kulik, MD, Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
- Hauptermittler: Riad Salem, MD, Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Kulik 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.
- Vouche 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2009
Primärer Abschluss (Tatsächlich)
1. Juli 2015
Studienabschluss (Tatsächlich)
1. September 2016
Studienanmeldedaten
Zuerst eingereicht
16. Februar 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Februar 2009
Zuerst gepostet (Schätzen)
18. Februar 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
15. September 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. September 2016
Zuletzt verifiziert
1. September 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen nach Standort
- Adenokarzinom
- Neubildungen, Drüsen und Epithelien
- Neoplasmen des Verdauungssystems
- Leberkrankheiten
- Lebertumoren
- Karzinom
- Karzinom, hepatozellulär
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Proteinkinase-Inhibitoren
- Sorafenib
Andere Studien-ID-Nummern
- NU08I4
- STU00005761 (Andere Kennung: Northwestern University IRB)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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