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NCT07607769
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.
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 200
Sponsor: AstraZeneca
Location: Research site Ancona
Summary
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.
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
Source: ClinicalTrials.gov (NCT07607769). StuddyBuddy aggregates publicly available trial information.
