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NCT07607769From ClinicalTrials.govRecruiting

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.

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)

  • Hepatocellular Carcinoma

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
AstraZeneca
Enrolment target
200
Started
16 April 2026
Main results due
31 October 2028
Study sites
24
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 100 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(24)

  • Research site

    Ancona, Italy

    Active, not recruiting

  • Research Site

    Ancona, Italy

    Recruiting

  • Research Site

    Bergamo, Italy

    Recruiting

  • Research site

    Foggia, Italy

    Recruiting

  • Research Site

    Foggia, Italy

    Recruiting

  • Research Site

    Meldola, Italy

    Recruiting

  • Research site

    Milan, Italy

    Active, not recruiting

  • Research Site

    Milan, Italy

    Recruiting

  • Research site

    Modena, Italy

    Active, not recruiting

  • Research Site

    Modena, Italy

    Recruiting

  • Research site

    Naples, Italy

    Recruiting

  • Research Site

    Naples, Italy

    Recruiting

  • Research Site

    Padova, Italy

    Recruiting

  • Research Site

    Palermo, Italy

    Recruiting

  • Research Site

    Pisa, Italy

    Recruiting

  • Research site

    Pozzuoli, Italy

    Active, not recruiting

  • Research Site

    Pozzuoli, Italy

    Recruiting

  • Research Site

    Roma, Italy

    Recruiting

  • Research site

    Rozzano, Italy

    Active, not recruiting

  • Research Site

    Rozzano, Italy

    Recruiting

  • Research site

    Torino, Italy

    Active, not recruiting

  • Research Site

    Torino, Italy

    Recruiting

  • Research site

    Verona, Italy

    Active, not recruiting

  • Research Site

    Verona, Italy

    Recruiting

Showing 24 of 24 sites. 17 of the 24 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07607769. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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MONTEROSA - Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quali | Trialion