MONTEROSA - Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment. (MONTEROSA)
26 de agosto de 2026 actualizado por: AstraZeneca
MONTEROSA Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment. (Real World Observational Study of STRIDE Regimen for Advanced HCC)
Italian multicenter observational study to evaluate time to clinical hepatic decompensation, quality of life, effectiveness, and safety of tremelimumab plus durvalumab in patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic treatment.
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Estimado)
200
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
- Número de teléfono: 9479 +1877240
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
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-
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Ancona, Italia, 60126
- Activo, no reclutando
- Research Site
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Bergamo, Italia, 24129
- Activo, no reclutando
- Research Site
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Foggia, Italia, 71122
- Reclutamiento
- Research Site
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Meldola, Italia, 47014
- Activo, no reclutando
- Research Site
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Milan, Italia, 20162
- Activo, no reclutando
- Research Site
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Milan, Italia, 20122
- Activo, no reclutando
- Research Site
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Modena, Italia, 41124
- Activo, no reclutando
- Research Site
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Naples, Italia, 80131
- Reclutamiento
- Research Site
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Padova, Italia, 35100
- Activo, no reclutando
- Research Site
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Palermo, Italia, 90127
- Activo, no reclutando
- Research Site
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Pisa, Italia, 56126
- Activo, no reclutando
- Research Site
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Pozzuoli, Italia, 80078
- Activo, no reclutando
- Research Site
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Roma, Italia, 00168
- Activo, no reclutando
- Research Site
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Rozzano, Italia, 20089
- Activo, no reclutando
- Research Site
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Torino, Italia, 10126
- Activo, no reclutando
- Research Site
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Verona, Italia, 37134
- Activo, no reclutando
- Research Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population will be made up of patients with histologically or radiologically confirmed advanced or uHCC not amenable to surgery and/or locoregional therapies, and without previous systemic therapy for HCC who are starting treatment with STRIDE as per routine clinical practice and independently of participation in this study.
The study aims to enroll approximately 200 patients.
Descripción
Inclusion Criteria:
- - Signed informed consent.
- Age ≥ 18 years.
- Histologically or radiologically confirmed diagnosis of advanced or unresectable HCC.
- BCLC B or C HCC.
- Child-Pugh A (score 5 or 6).
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1.
- Planned first-line treatment of advanced/uHCC with STRIDE.
Exclusion Criteria:
- - Any previous line of systemic therapy for HCC.
- Any prior or concomitant immunotherapy.
- Prior allogeneic organ or bone marrow transplant.
- Documented active or previous GI bleeding within the previous 12 months.
- Main trunk portal vein thrombosis.
- Autoimmune disease requiring treatment with immunosuppressive medication.
- Known hypersensitivity to the active substance or to any of the STRIDE excipients.
- Pregnancy or breastfeeding
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
aHCC/uHCC
patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice.
|
Tremelimumab 300 mg as a single dose administered in combination with durvalumab 1500 mg at Cycle 1/Day 1, followed by durvalumab monotherapy every 4 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time To Decompensation (TTDec)
Periodo de tiempo: From index date to first hepatic decompensation/study completion, up to 30 months
|
time from index date (start of new treatment) to the first occurrence of events such as ascites of any grade according to the European Association for the Study of the Liver (EASL) classification, hepatic encephalopathy of any grade according to West Haven classification, variceal hemorrhage, or jaundice (total bilirubin >3 mg/dL). In Child-Pugh (CP)-A participants with a score of 6 at index date, TTDec is defined as the time from index date to any worsening in ascites, hepatic encephalopathy, variceal hemorrhage, or jaundice (defined as an increase in total bilirubin to greater than 3 mg/dL or a worsening of more than 1.0 mg/dL from index date). At the time of decompensation (± 30 days) a CT scan should be performed to exclude worsening of liver function due to tumor progression. |
From index date to first hepatic decompensation/study completion, up to 30 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time To Worsening (TTWors)
Periodo de tiempo: Baseline and every 8 weeks during treatment, up to 30 months
|
Time To Worsening (TTWors) based on the EORTC QLQ-C30 and QLQ-HCC18 PROs within the first 18 months of treatment.
TTWors is the time from first treatment to first clinically meaningful deterioration confirmed at a subsequent visit/assessment or death from any cause.
A clinically meaningful change (deterioration or improvement) is defined as an absolute change ≥ 10 points in total score from index date.
|
Baseline and every 8 weeks during treatment, up to 30 months
|
|
Overall Survival (OS)
Periodo de tiempo: From index date through study completion, up to 30 months
|
time from first treatment to death
|
From index date through study completion, up to 30 months
|
|
Progression free survival (PFS)
Periodo de tiempo: From index date until tumor progression, assessed until study completion, up to 30 months
|
time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1).
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From index date until tumor progression, assessed until study completion, up to 30 months
|
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Overall response rate (ORR)
Periodo de tiempo: From index date until objective tumor progression, assessed until study completion, up to 30 months
|
proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1.
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From index date until objective tumor progression, assessed until study completion, up to 30 months
|
|
Disease Control Rate (DCR)
Periodo de tiempo: From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
|
proportion of participants with a CR, PR, or stable disease (SD) per RECIST v1.1.
(stable disease needs to be maintained for a minimum of 8 weeks to be included in the DCR).
|
From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
|
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Downstaging
Periodo de tiempo: From index date until study completion, up to 30 months
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Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen
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From index date until study completion, up to 30 months
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safety
Periodo de tiempo: From index date until study completion, up to 33 months
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Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome.
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From index date until study completion, up to 33 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
TTDec subgroups
Periodo de tiempo: From index date to first hepatic decompensation/study completion, up to 30 months
|
defined for the primary outcome within the first 18 months of treatment by: • Baseline ALBI grade (1 vs 2 or 3) • Cirrhosis at baseline (yes vs no) • Signs of portal hypertension at baseline, i.e., splenomegaly and thrombocytopenia and presence of collateral circulation, or porto-systemic shunts (yes vs no) |
From index date to first hepatic decompensation/study completion, up to 30 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de abril de 2026
Finalización primaria (Estimado)
31 de octubre de 2028
Finalización del estudio (Estimado)
31 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
23 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D419CR00060
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.
Marco de tiempo para compartir IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles.
For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Criterios de acceso compartido de IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .