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 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Studietype
Observationeel
Inschrijving (Geschat)
200
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
- Telefoonnummer: 9479 +1877240
- E-mail: information.center@astrazeneca.com
Studie Locaties
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Ancona, Italië, 60126
- Actief, niet wervend
- Research Site
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Bergamo, Italië, 24129
- Actief, niet wervend
- Research Site
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Foggia, Italië, 71122
- Werving
- Research Site
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Meldola, Italië, 47014
- Actief, niet wervend
- Research Site
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Milan, Italië, 20162
- Actief, niet wervend
- Research Site
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Milan, Italië, 20122
- Actief, niet wervend
- Research Site
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Modena, Italië, 41124
- Actief, niet wervend
- Research Site
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Naples, Italië, 80131
- Werving
- Research Site
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Padova, Italië, 35100
- Actief, niet wervend
- Research Site
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Palermo, Italië, 90127
- Actief, niet wervend
- Research Site
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Pisa, Italië, 56126
- Actief, niet wervend
- Research Site
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Pozzuoli, Italië, 80078
- Actief, niet wervend
- Research Site
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Roma, Italië, 00168
- Actief, niet wervend
- Research Site
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Rozzano, Italië, 20089
- Actief, niet wervend
- Research Site
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Torino, Italië, 10126
- Actief, niet wervend
- Research Site
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Verona, Italië, 37134
- Actief, niet wervend
- Research Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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aHCC/uHCC
patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time To Decompensation (TTDec)
Tijdsspanne: From index date to first hepatic decompensation/study completion, up to 30 months
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time To Worsening (TTWors)
Tijdsspanne: Baseline and every 8 weeks during treatment, up to 30 months
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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.
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Baseline and every 8 weeks during treatment, up to 30 months
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Overall Survival (OS)
Tijdsspanne: From index date through study completion, up to 30 months
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time from first treatment to death
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From index date through study completion, up to 30 months
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Progression free survival (PFS)
Tijdsspanne: From index date until tumor progression, assessed until study completion, up to 30 months
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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)
Tijdsspanne: From index date until objective tumor progression, assessed until study completion, up to 30 months
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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
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Disease Control Rate (DCR)
Tijdsspanne: From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
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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).
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From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
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Downstaging
Tijdsspanne: 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
Tijdsspanne: 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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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TTDec subgroups
Tijdsspanne: From index date to first hepatic decompensation/study completion, up to 30 months
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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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 april 2026
Primaire voltooiing (Geschat)
31 oktober 2028
Studie voltooiing (Geschat)
31 oktober 2028
Studieregistratiedata
Eerst ingediend
23 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
21 mei 2026
Eerst geplaatst (Werkelijk)
26 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
26 augustus 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D419CR00060
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
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.
IPD-toegangscriteria voor delen
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .