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.

time from index date (start of new treatment) to the first occurrence of events such as ascites of any grade according to the European Association for the Study of the Liver (EASL) classification, hepatic encephalopathy of any grade according to West Haven classification, variceal hemorrhage, or jaundice (total bilirubin >3 mg/dL).

In Child-Pugh (CP)-A participants with a score of 6 at index date, TTDec is defined as the time from index date to any worsening in ascites, hepatic encephalopathy, variceal hemorrhage, or jaundice (defined as an increase in total bilirubin to greater than 3 mg/dL or a worsening of more than 1.0 mg/dL from index date).

At the time of decompensation (± 30 days) a CT scan should be performed to exclude worsening of liver function due to tumor progression.

Time To Worsening (TTWors) based on the EORTC QLQ-C30 and QLQ-HCC18 PROs within the first 18 months of treatment. TTWors is the time from first treatment to first clinically meaningful deterioration confirmed at a subsequent visit/assessment or death from any cause. A clinically meaningful change (deterioration or improvement) is defined as an absolute change ≥ 10 points in total score from index date.

time from first treatment to death

time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1).

proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1.

proportion of participants with a CR, PR, or stable disease (SD) per RECIST v1.1. (stable disease needs to be maintained for a minimum of 8 weeks to be included in the DCR).

Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen

Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome.

defined for the primary outcome within the first 18 months of treatment by:

• Baseline ALBI grade (1 vs 2 or 3)

• Cirrhosis at baseline (yes vs no)

• Signs of portal hypertension at baseline, i.e., splenomegaly and thrombocytopenia and presence of collateral circulation, or porto-systemic shunts (yes vs no)