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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STRIDE.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Time To Decompensation (TTDec) [Time frame: From index date to first hepatic decompensation/study completion, up to 30 months]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 24 centers
- Research site — Ancona
- Research Site — Ancona
- Research Site — Bergamo
- Research site — Foggia
- Research Site — Foggia
- Research Site — Meldola
- Research site — Milan
- Research Site — Milan
- … and 16 more centers
Identifiers
NCT: NCT07607769 · D419CR00060