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. (MONTEROSA)

May 21, 2026 updated by: AstraZeneca

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. (Real World Observational Study of STRIDE Regimen for Advanced HCC)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy, 60126
        • Active, not recruiting
        • Research Site
      • Bergamo, Italy, 24129
        • Active, not recruiting
        • Research Site
      • Foggia, Italy, 71122
        • Recruiting
        • Research Site
      • Meldola, Italy, 47014
        • Active, not recruiting
        • Research Site
      • Milan, Italy, 20162
        • Active, not recruiting
        • Research Site
      • Milan, Italy, 20122
        • Active, not recruiting
        • Research Site
      • Modena, Italy, 41124
        • Active, not recruiting
        • Research Site
      • Naples, Italy, 80131
        • Recruiting
        • Research Site
      • Padova, Italy, 35100
        • Active, not recruiting
        • Research Site
      • Palermo, Italy, 90127
        • Active, not recruiting
        • Research Site
      • Pisa, Italy, 56126
        • Active, not recruiting
        • Research Site
      • Pozzuoli, Italy, 80078
        • Active, not recruiting
        • Research Site
      • Roma, Italy, 00168
        • Active, not recruiting
        • Research Site
      • Rozzano, Italy, 20089
        • Active, not recruiting
        • Research Site
      • Torino, Italy, 10126
        • Active, not recruiting
        • Research Site
      • Verona, Italy, 37134
        • Active, not recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be made up of patients with histologically or radiologically confirmed advanced or uHCC not amenable to surgery and/or locoregional therapies, and without previous systemic therapy for HCC who are starting treatment with STRIDE as per routine clinical practice and independently of participation in this study. The study aims to enroll approximately 200 patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
aHCC/uHCC
patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice.
Drug: STRIDE
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Decompensation (TTDec)
Time Frame: From index date to first hepatic decompensation/study completion, up to 30 months

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Worsening (TTWors)
Time Frame: Baseline and every 8 weeks during treatment, up to 30 months
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.
Baseline and every 8 weeks during treatment, up to 30 months
Overall Survival (OS)
Time Frame: From index date through study completion, up to 30 months
time from first treatment to death
From index date through study completion, up to 30 months
Progression free survival (PFS)
Time Frame: From index date until tumor progression, assessed until study completion, up to 30 months
time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1).
From index date until tumor progression, assessed until study completion, up to 30 months
Overall response rate (ORR)
Time Frame: From index date until objective tumor progression, assessed until study completion, up to 30 months
proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1.
From index date until objective tumor progression, assessed until study completion, up to 30 months
Disease Control Rate (DCR)
Time Frame: From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
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).
From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
Downstaging
Time Frame: From index date until study completion, up to 30 months
Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen
From index date until study completion, up to 30 months
safety
Time Frame: From index date until study completion, up to 33 months
Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome.
From index date until study completion, up to 33 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTDec subgroups
Time Frame: From index date to first hepatic decompensation/study completion, up to 30 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D419CR00060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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