Une étude américaine visant à évaluer la radioembolisation transartérielle (TARE) en association avec le traitement par le durvalumab et le bevacizumab chez les personnes atteintes d'un carcinome hépatocellulaire non résécable susceptible d'être traité par TARE (EMERALD-Y90)
Étude de phase II à un seul bras sur le durvalumab et le bevacizumab après radioembolisation transartérielle à l'aide de microsphères de verre d'yttrium-90 (TheraSphere™) dans le carcinome hépatocellulaire non résécable se prêtant à un traitement locorégional
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Research Site
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Florida
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Gainesville, Florida, États-Unis, 32608
- Research Site
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Orlando, Florida, États-Unis, 32804
- Research Site
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Research Site
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Atlanta, Georgia, États-Unis, 30342
- Research Site
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Research Site
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Research Site
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Michigan
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Detroit, Michigan, États-Unis, 48201
- Research Site
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Research Site
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New Jersey
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Trenton, New Jersey, États-Unis, 08690
- Research Site
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New York
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Buffalo, New York, États-Unis, 14263
- Research Site
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New York, New York, États-Unis, 10029
- Research Site
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- Research Site
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Research Site
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Oregon
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Portland, Oregon, États-Unis, 97239
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Research Site
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Texas
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Houston, Texas, États-Unis, 77030
- Research Site
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- Research Site
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Washington
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Seattle, Washington, États-Unis, 98195
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Research Site
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Milwaukee, Wisconsin, États-Unis, 53215
- Research Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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)
Autres noms:
Bevacizumab IV (intravenous)
Autres noms:
Yttrium 90 glass microspheres will be administered
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Progression Free Survival (PFS)
Délai: 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]
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants with Adverse events (AEs)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies du foie
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Carcinome
- Carcinome hépatocellulaire
- Tumeurs du foie
- Acides aminés, peptides et protéines
- Protéines
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Bévacizumab
- durvalumab
Autres numéros d'identification d'étude
- D933GC00002
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Délai de partage IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critères d'accès au partage IPD
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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