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.

Browse trials for

• Carcinoma, Hepatocellular 3,176

Study population

Groups and cohorts

• aHCC/uHCC

  patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice.

  Drug: STRIDE

Interventions

• DrugSTRIDE

  Tremelimumab 300 mg as a single dose administered in combination with durvalumab 1500 mg at Cycle 1/Day 1, followed by durvalumab monotherapy every 4 weeks.

Primary outcomes

1. Time To Decompensation (TTDec)

   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 frame: From index date to first hepatic decompensation/study completion, up to 30 months

Secondary outcomes

1. Time To Worsening (TTWors)

   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 frame: Baseline and every 8 weeks during treatment, up to 30 months

2. Overall Survival (OS)

   time from first treatment to death

   Time frame: From index date through study completion, up to 30 months

3. Progression free survival (PFS)

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

   Time frame: From index date until tumor progression, assessed until study completion, up to 30 months

4. Overall response rate (ORR)

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

   Time frame: From index date until objective tumor progression, assessed until study completion, up to 30 months

5. Disease Control Rate (DCR)

   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).

   Time frame: From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months

6. Downstaging

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

   Time frame: From index date until study completion, up to 30 months

7. safety

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

   Time frame: From index date until study completion, up to 33 months

Other outcomes

1. TTDec subgroups

   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)

   Time frame: From index date to first hepatic decompensation/study completion, up to 30 months

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.