Health Trials

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.

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAstraZeneca

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.

Eligibility criteria

Qualifiers

- Signed informed consent.

Age ≥ 18 years.

Histologically or radiologically confirmed diagnosis of advanced or unresectable HCC.

BCLC B or C HCC.

Disqualifiers

- 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.

Trial design

Treatments tested in this trial

  • STRIDE

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov