Italian Observational Study of Tremelimumab Plus Durvalumab Treatment in Adults with Advanced or Unresectable Hepatocellular Carcinoma Without Prior Systemic Therapy

What this Trial Is About

Researchers are evaluating the time to clinical liver decompensation, quality of life, effectiveness, and safety of the combination of tremelimumab plus durvalumab, known as STRIDE, in patients with advanced or unresectable hepatocellular carcinoma HCC who have not received any prior systemic treatment. This observational Italian multicenter study focuses on real-world patients with advanced or unresectable HCC to better understand the impact of STRIDE in routine clinical practice. Participants in this study receive a single dose of tremelimumab 300 mg combined with durvalumab 1500 mg on the first day of treatment cycle, followed by durvalumab alone every 4 weeks. The treatment is given according to routine clinical care in Italy, and patients are observed over time to collect data on outcomes and safety. During the study, participants will be monitored up to 30 months for various outcomes including time to first hepatic decompensation, time to disease worsening, overall survival, progression-free survival, tumor response rates, disease control, and safety. Assessments include clinical evaluations and data collection at baseline and regular intervals during treatment. The study aims to provide detailed information on how patients respond and tolerate STRIDE in everyday clinical settings.

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.