NCT07607769 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.
| NCT ID | NCT07607769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-16 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-04-16 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
✉ information.center@astrazeneca.com📞 +1877240
Frequently Asked Questions
Who can join the NCT07607769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07607769 currently recruiting?
Yes, NCT07607769 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07607769 trial being conducted?
This trial is being conducted at Ancona, Italy, Bergamo, Italy, Foggia, Italy, Meldola, Italy and 11 additional locations.
Who is sponsoring the NCT07607769 clinical trial?
NCT07607769 is sponsored by AstraZeneca. The trial plans to enroll 200 participants.
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