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.

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Time To Decompensation (TTDec) [Срок оценки: From index date to first hepatic decompensation/study completion, up to 30 months]

Вторичные конечные точки (7)

• Time To Worsening (TTWors) [Срок оценки: Baseline and every 8 weeks during treatment, up to 30 months]
• Overall Survival (OS) [Срок оценки: From index date through study completion, up to 30 months]
• Progression free survival (PFS) [Срок оценки: From index date until tumor progression, assessed until study completion, up to 30 months]
• Overall response rate (ORR) [Срок оценки: From index date until objective tumor progression, assessed until study completion, up to 30 months]
• Disease Control Rate (DCR) [Срок оценки: From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months]
• Downstaging [Срок оценки: From index date until study completion, up to 30 months]
• safety [Срок оценки: From index date until study completion, up to 33 months]

Критерии участия

Критерии включения

• \- 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.

Критерии исключения

• \- 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 24 центра

• Research site — Ancona
• Research Site — Ancona
• Research Site — Bergamo
• Research site — Foggia
• Research Site — Foggia
• Research Site — Meldola
• Research site — Milan
• Research Site — Milan
• … и ещё 16 центров

Идентификаторы

NCT: NCT07607769 · D419CR00060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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