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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.

Study acronym: MONTEROSA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 16 → 24 locations Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 2 of 7 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Trial sites reduced: 24 → 16 locationsv4
  3. Trial sites expanded: 16 → 24 locationsv3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
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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.
Trial Details
NCT Number NCT07607769
Lead Sponsor AstraZeneca
Conditions Hepatocellular Carcinoma
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov