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.

Sponsor
AstraZeneca
Study ID
NCT07607769
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • STRIDE — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 26, 2026
Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: aHCC/uHCC
    patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice.

Primary Outcome Measure

Time To Decompensation (TTDec) [ Time Frame: From index date to first hepatic decompensation/study completion, up to 30 months ]

Central Contacts

  • AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
    +1877240
    [email protected]

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