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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.

Recruitingn/aAges 18 Years - 100 YearsAllAstraZeneca
NCT07607769 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • STRIDE
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Where

24 sites
Research site
Ancona, Italy
Research Site
Ancona, Italy
Research Site
Bergamo, Italy
Research site
Foggia, Italy
Research Site
Foggia, Italy
Research Site
Meldola, Italy
Research site
Milan, Italy
Research Site
Milan, Italy

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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