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. august 2026 oppdatert av: 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.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Antatt)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
- Telefonnummer: 9479 +1877240
- E-post: information.center@astrazeneca.com
Studiesteder
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-
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Ancona, Italia, 60126
- Aktiv, ikke rekrutterende
- Research Site
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Bergamo, Italia, 24129
- Aktiv, ikke rekrutterende
- Research Site
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Foggia, Italia, 71122
- Rekruttering
- Research Site
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Meldola, Italia, 47014
- Aktiv, ikke rekrutterende
- Research Site
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Milan, Italia, 20162
- Aktiv, ikke rekrutterende
- Research Site
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Milan, Italia, 20122
- Aktiv, ikke rekrutterende
- Research Site
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Modena, Italia, 41124
- Aktiv, ikke rekrutterende
- Research Site
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Naples, Italia, 80131
- Rekruttering
- Research Site
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Padova, Italia, 35100
- Aktiv, ikke rekrutterende
- Research Site
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Palermo, Italia, 90127
- Aktiv, ikke rekrutterende
- Research Site
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Pisa, Italia, 56126
- Aktiv, ikke rekrutterende
- Research Site
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Pozzuoli, Italia, 80078
- Aktiv, ikke rekrutterende
- Research Site
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Roma, Italia, 00168
- Aktiv, ikke rekrutterende
- Research Site
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Rozzano, Italia, 20089
- Aktiv, ikke rekrutterende
- Research Site
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Torino, Italia, 10126
- Aktiv, ikke rekrutterende
- Research Site
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Verona, Italia, 37134
- Aktiv, ikke rekrutterende
- Research Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time To Decompensation (TTDec)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time To Worsening (TTWors)
Tidsramme: 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.
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Baseline and every 8 weeks during treatment, up to 30 months
|
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Overall Survival (OS)
Tidsramme: From index date through study completion, up to 30 months
|
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)
Tidsramme: 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)
Tidsramme: 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
|
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Disease Control Rate (DCR)
Tidsramme: 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).
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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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TTDec subgroups
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. april 2026
Primær fullføring (Antatt)
31. oktober 2028
Studiet fullført (Antatt)
31. oktober 2028
Datoer for studieregistrering
Først innsendt
23. april 2026
Først innsendt som oppfylte QC-kriteriene
21. mai 2026
Først lagt ut (Faktiske)
26. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D419CR00060
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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