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.

Official record

Identifier

NCT07607769

Recruiting locations

country

Italy

Interventions studied

STRIDE

Lead sponsor

AstraZeneca

Target enrolment

200 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Recruiting

First posted

May 26, 2026

Last updated on the registry

Jul 27, 2026

Age

18 Years – 100 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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