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 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
200
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 9479 +1877240
- E-mail: information.center@astrazeneca.com
Lieux d'étude
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Ancona, Italie, 60126
- Actif, ne recrute pas
- Research Site
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Bergamo, Italie, 24129
- Actif, ne recrute pas
- Research Site
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Foggia, Italie, 71122
- Recrutement
- Research Site
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Meldola, Italie, 47014
- Actif, ne recrute pas
- Research Site
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Milan, Italie, 20162
- Actif, ne recrute pas
- Research Site
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Milan, Italie, 20122
- Actif, ne recrute pas
- Research Site
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Modena, Italie, 41124
- Actif, ne recrute pas
- Research Site
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Naples, Italie, 80131
- Recrutement
- Research Site
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Padova, Italie, 35100
- Actif, ne recrute pas
- Research Site
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Palermo, Italie, 90127
- Actif, ne recrute pas
- Research Site
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Pisa, Italie, 56126
- Actif, ne recrute pas
- Research Site
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Pozzuoli, Italie, 80078
- Actif, ne recrute pas
- Research Site
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Roma, Italie, 00168
- Actif, ne recrute pas
- Research Site
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Rozzano, Italie, 20089
- Actif, ne recrute pas
- Research Site
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Torino, Italie, 10126
- Actif, ne recrute pas
- Research Site
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Verona, Italie, 37134
- Actif, ne recrute pas
- Research Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time To Decompensation (TTDec)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time To Worsening (TTWors)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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.
|
From index date until study completion, up to 33 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
TTDec subgroups
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
16 avril 2026
Achèvement primaire (Estimé)
31 octobre 2028
Achèvement de l'étude (Estimé)
31 octobre 2028
Dates d'inscription aux études
Première soumission
23 avril 2026
Première soumission répondant aux critères de contrôle qualité
21 mai 2026
Première publication (Réel)
26 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D419CR00060
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
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 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.
Délai de partage 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.
Critères d'accès au partage 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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .