Hepatocellular CarcinomaMONTEROSANCT07607769
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.
An observational study of Hepatocellular Carcinoma, run by AstraZeneca at 24 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- STRIDE
- How many people
- 200 participants
- Where
- 24 sitesItaly
- Study dates
- 16 Apr 2026to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- - 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.
Who cannot join
- - 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
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center contact
24 sites in 1 country
Italy24 sites, 17 recruiting
- Active, not recruiting
Research site
Ancona, 60126
- Recruiting
Research Site
Ancona
- Recruiting
Research Site
Bergamo
- Recruiting
Research site
Foggia, 71122
- Recruiting
Research Site
Foggia
- Recruiting
Research Site
Meldola
- Active, not recruiting
Research site
Milan, 20122
- Recruiting
Research Site
Milan
- Active, not recruiting
Research site
Modena, 41124
- Recruiting
Research Site
Modena
- Recruiting
Research site
Naples, 80131
- Recruiting
Research Site
Naples
- Recruiting
Research Site
Padova
- Recruiting
Research Site
Palermo
- Recruiting
Research Site
Pisa
- Active, not recruiting
Research site
Pozzuoli, 80078
- Recruiting
Research Site
Pozzuoli
- Recruiting
Research Site
Roma
- Active, not recruiting
Research site
Rozzano, 20089
- Recruiting
Research Site
Rozzano
- Active, not recruiting
Research site
Torino, 10126
- Recruiting
Research Site
Torino
- Active, not recruiting
Research site
Verona, 37134
- Recruiting
Research Site
Verona
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- STRIDE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIDEDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| aHCC/uHCC | patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice. Receives: Drug: STRIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From index date to first hepatic decompensation/study completion, up to 30 months
Secondary outcomes (7)
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.
Measured: Baseline and every 8 weeks during treatment, up to 30 months
Overall Survival (OS)
time from first treatment to death
Measured: From index date through study completion, up to 30 months
Progression free survival (PFS)
time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1).
Measured: From index date until tumor progression, assessed until study completion, up to 30 months
Overall response rate (ORR)
proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1.
Measured: From index date until objective tumor progression, assessed until study completion, up to 30 months
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).
Measured: From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
Downstaging
Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen
Measured: From index date until study completion, up to 30 months
safety
Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome.
Measured: From index date until study completion, up to 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start16 Apr 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607769
- Sponsor's protocol ID
- D419CR00060
- Acronym
- MONTEROSA
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07607769
- Acronym / sponsor ID
- MONTEROSA / D419CR00060
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aHCC/uHCC | – | Drug: STRIDEpatients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- - 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).
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIDETremelimumab 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. | Drug | aHCC/uHCC |
Primary outcome
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.
7 secondary outcomes
Time To Worsening (TTWors)
Time frame: 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
Progression free survival (PFS)
Time frame: 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
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
Downstaging
Time frame: From index date until study completion, up to 30 months
safety
Time frame: From index date until study completion, up to 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center contact
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by AstraZeneca at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center (+1877240 ext. 9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To Decompensation (TTDec) (time frame: From index date to first hepatic decompensation/study completion, up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.