Clinical Trial

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.

Study acronym: MONTEROSA
Recruiting
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Summary
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.
Protocol Amendment History 1 change
notable Trial sites expanded: 16 -> 24 locations 2026-07-28
Trial Details
NCT Number NCT07607769
Lead Sponsor AstraZeneca
Conditions Hepatocellular Carcinoma
Enrollment 200 participants
Start Date 2026-04-16
Primary Completion 2028-10-31 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-27