Um estudo dos EUA para avaliar a radioembolização transarterial (TARE) em combinação com a terapia com durvalumabe e bevacizumabe em pessoas com carcinoma hepatocelular irressecável passível de TARE (EMERALD-Y90)
Estudo de fase II de braço único de durvalumabe e bevacizumabe após radioembolização transarterial usando microesferas de vidro de ítrio-90 (TheraSphere™) em carcinoma hepatocelular irressecável passível de terapia locorregional
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Research Site
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Florida
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Gainesville, Florida, Estados Unidos, 32608
- Research Site
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Orlando, Florida, Estados Unidos, 32804
- Research Site
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Research Site
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Atlanta, Georgia, Estados Unidos, 30342
- Research Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Research Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Research Site
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Research Site
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Research Site
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New Jersey
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Trenton, New Jersey, Estados Unidos, 08690
- Research Site
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New York
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Buffalo, New York, Estados Unidos, 14263
- Research Site
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New York, New York, Estados Unidos, 10029
- Research Site
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Research Site
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Research Site
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Research Site
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Texas
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Houston, Texas, Estados Unidos, 77030
- Research Site
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Research Site
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Washington
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Seattle, Washington, Estados Unidos, 98195
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Research Site
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Milwaukee, Wisconsin, Estados Unidos, 53215
- Research Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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)
Outros nomes:
Bevacizumab IV (intravenous)
Outros nomes:
Yttrium 90 glass microspheres will be administered
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Progression Free Survival (PFS)
Prazo: 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]
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants with Adverse events (AEs)
Prazo: From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
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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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças do Fígado
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Carcinoma
- Carcinoma Hepatocelular
- Neoplasias Hepáticas
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Anticorpos, monoclonais, humanizados
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Bevacizumabe
- durValumab
Outros números de identificação do estudo
- D933GC00002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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