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

Locations

Research site60126, Ancona Italy

Research site24129, Bergamo Italy

Research site71122, Foggia Italy

Research site47014, Meldola Italy

Sponsors and collaborators

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov