Eine US-Studie zur Bewertung der transarteriellen Radioembolisation (TARE) in Kombination mit der Durvalumab- und Bevacizumab-Therapie bei Menschen mit nicht resezierbarem hepatozellulärem Karzinom, das für TARE geeignet ist (EMERALD-Y90)
Einarmige Phase-II-Studie zu Durvalumab und Bevacizumab nach transarterieller Radioembolisation unter Verwendung von Yttrium-90-Glasmikrosphären (TheraSphere™) bei nicht resezierbarem hepatozellulärem Karzinom, das für eine lokoregionale Therapie geeignet ist
The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant.
Participants with previous Transarterial Chemoembolization (TACE) or TARE associated with the curative setting are permitted with a 6-month washout.
Approximately 120 participants with unresectable but amenable to locoregional therapy HCC eligible for embolization will be screened in the study at approximately 20 sites in the US to enroll approximately 60 participants.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- Research Site
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Florida
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Gainesville, Florida, Vereinigte Staaten, 32608
- Research Site
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Orlando, Florida, Vereinigte Staaten, 32804
- Research Site
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Research Site
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Research Site
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Research Site
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02118
- Research Site
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48201
- Research Site
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110
- Research Site
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New Jersey
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Trenton, New Jersey, Vereinigte Staaten, 08690
- Research Site
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New York
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Buffalo, New York, Vereinigte Staaten, 14263
- Research Site
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New York, New York, Vereinigte Staaten, 10029
- Research Site
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599
- Research Site
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- Research Site
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
- Research Site
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- Research Site
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Virginia
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Charlottesville, Virginia, Vereinigte Staaten, 22908
- Research Site
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Washington
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Seattle, Washington, Vereinigte Staaten, 98195
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Research Site
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Milwaukee, Wisconsin, Vereinigte Staaten, 53215
- Research Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Participants with confirmed unresectable HCC
- Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume.
- Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR > 30%.
- Participants with no evidence of extrahepatic disease on any available imaging
- Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
- Participants having Child-Pugh score class A.
- Participants having ECOG performance status of 0 or 1 at enrollment
- Adequate organ and marrow function
Exclusion Criteria:
- Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
- Participants co-infected with HBV and HDV
- Any history of nephrotic or nephritic syndrome.
- Clinically significant (eg, active) cardiovascular disease
- Participants with uncontrolled hypertension
- History of hepatic encephalopathy
- Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
- Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
- Participant has received any prior anticancer systemic therapy for unresectable HCC.
- History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
- History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab
Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation. |
Durvalumab IV (intravenous)
Andere Namen:
Bevacizumab IV (intravenous)
Andere Namen:
Yttrium 90 glass microspheres will be administered
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Progression Free Survival (PFS)
Zeitfenster: From Day 1 until date of progressive disease or death [Approximately 3 years]
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PFS is defined as the time from Day 1 (day of TARE) until the date of progressive disease per modified Response Evaluation Criteria in Solid Tumors (mRECIST), as assessed by the investigator, or death due to any cause. It is measured to assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
From Day 1 until date of progressive disease or death [Approximately 3 years]
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of participants with Adverse events (AEs)
Zeitfenster: From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
|
To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy |
From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
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Objective Response Rate (ORR)
Zeitfenster: From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years)
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ORR is defined as the proportion of participants who have a confirmed complete response or partial response, as determined by the investigator per mRECIST. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years)
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Overall Survival (OS)
Zeitfenster: Day 1 to 18 months or until death (Approximately 3 years)
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OS is defined as the time from the start of TARE until the date of death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
Day 1 to 18 months or until death (Approximately 3 years)
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Duration of Response (DoR)
Zeitfenster: Time from first documented response until documented progression (Approximately 3 years)
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DoR is defined as the time from the date of first documented response (that is subsequently confirmed) until the date of documented progression per mRECIST as assessed by the investigator, or death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy. |
Time from first documented response until documented progression (Approximately 3 years)
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Neubildungen nach histologischem Typ
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Leberkrankheiten
- Neubildungen, Drüsen und Epithelien
- Adenokarzinom
- Karzinom
- Karzinom, hepatozellulär
- Lebertumoren
- Aminosäuren, Peptide und Proteine
- Proteine
- Antikörper, monoklonal, humanisiert
- Antikörper, monoklonal
- Antikörper
- Immunglobuline
- Immunoproteine
- Blutproteine
- Serumglobuline
- Globuline
- Bevacizumab
- Durvalumab
Andere Studien-ID-Nummern
- D933GC00002
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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IPD-Sharing-Zeitrahmen
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Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
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