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 augusti 2026 uppdaterad 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.
Studieöversikt
Studietyp
Observationell
Inskrivning (Beräknad)
200
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
- Telefonnummer: 9479 +1877240
- E-post: information.center@astrazeneca.com
Studieorter
-
-
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Ancona, Italien, 60126
- Aktiv, inte rekryterande
- Research Site
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Bergamo, Italien, 24129
- Aktiv, inte rekryterande
- Research Site
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Foggia, Italien, 71122
- Rekrytering
- Research Site
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Meldola, Italien, 47014
- Aktiv, inte rekryterande
- Research Site
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Milan, Italien, 20162
- Aktiv, inte rekryterande
- Research Site
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Milan, Italien, 20122
- Aktiv, inte rekryterande
- Research Site
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Modena, Italien, 41124
- Aktiv, inte rekryterande
- Research Site
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Naples, Italien, 80131
- Rekrytering
- Research Site
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Padova, Italien, 35100
- Aktiv, inte rekryterande
- Research Site
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Palermo, Italien, 90127
- Aktiv, inte rekryterande
- Research Site
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Pisa, Italien, 56126
- Aktiv, inte rekryterande
- Research Site
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Pozzuoli, Italien, 80078
- Aktiv, inte rekryterande
- Research Site
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Roma, Italien, 00168
- Aktiv, inte rekryterande
- Research Site
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Rozzano, Italien, 20089
- Aktiv, inte rekryterande
- Research Site
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Torino, Italien, 10126
- Aktiv, inte rekryterande
- Research Site
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Verona, Italien, 37134
- Aktiv, inte rekryterande
- Research Site
-
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time To Decompensation (TTDec)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time To Worsening (TTWors)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
|
Overall response rate (ORR)
Tidsram: 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
|
|
Disease Control Rate (DCR)
Tidsram: 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
Tidsram: From index date until study completion, up to 30 months
|
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
|
|
safety
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
TTDec subgroups
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 april 2026
Primärt slutförande (Beräknad)
31 oktober 2028
Avslutad studie (Beräknad)
31 oktober 2028
Studieregistreringsdatum
Först inskickad
23 april 2026
Först inskickad som uppfyllde QC-kriterierna
21 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D419CR00060
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .