MONTEROSA - Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompen… (NCT07607769) | Clinical Trial Compass
RecruitingNot Applicable
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.
Italy200 participantsStarted 2026-04-16
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time To Decompensation (TTDec)
Timeframe: From index date to first hepatic decompensation/study completion, up to 30 months
Trial details
NCT IDNCT07607769
SponsorAstraZeneca
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2028-10-31
Contact for this trial
AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center