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.
Recruiting
Observational Study
Hepatocellular Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Study type
- Observational
- Participants needed
- 200 (estimated)
- Sponsor
- AstraZeneca · Industry
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About This Trial
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.
Trial Locations
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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-…
Contacts
AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
+1877240
information.center@astrazeneca.com
CONTACT