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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
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-04-16
Completion Date
2028-10-31
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
STRIDE
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.
Locations (16)
Research site
Ancona, Italy
Research site
Bergamo, Italy
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Foggia, Italy
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Meldola, Italy
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Milan, Italy
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Milan, Italy
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Modena, Italy
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Naples, Italy
Research site
Padova, Italy
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Palermo, Italy
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Pisa, Italy
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Pozzuoli, Italy
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Roma, Italy
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Rozzano, Italy
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Torino, Italy
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Verona, Italy