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.
Recruiting now
Conditions studied: Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07607769
- Run by
- AstraZeneca
- People needed
- 200
- Starts
- 2026-04-16
- Expected to finish
- 2028-10-31
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- - 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.
You may not qualify if…
- - 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
Where it is running
- Research Site — Foggia, Italy (enrolling)
- Research Site — Pozzuoli, Italy (enrolling)
- Research Site — Roma, Italy (enrolling)
- Research Site — Meldola, Italy (enrolling)
- Research Site — Rozzano, Italy (enrolling)
- Research Site — Ancona, Italy (enrolling)
- Research Site — Torino, Italy (enrolling)
- Research Site — Milan, Italy (enrolling)
- Research Site — Bergamo, Italy (enrolling)
- Research site — Foggia, Italy (enrolling)
- Research site — Naples, Italy (enrolling)
- Research Site — Naples, Italy (enrolling)
- Research Site — Padova, Italy (enrolling)
- Research Site — Palermo, Italy (enrolling)
- Research Site — Pisa, Italy (enrolling)
- Research Site — Verona, Italy
- Research site — Milan, Italy
- Research site — Modena, Italy
- Research Site — Modena, Italy
- Research site — Pozzuoli, Italy
- Research site — Rozzano, Italy
- Research site — Torino, Italy
- Research site — Verona, Italy
- Research site — Ancona, Italy
Full record on ClinicalTrials.gov
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