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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 31
- 主要终点
- Time To Decompensation (TTDec)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
- •Planned first-line treatment of advanced/uHCC with STRIDE.
排除标准
- •- 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
研究组 & 干预措施
aHCC/uHCC
patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice.
干预措施: STRIDE (Drug)
结局指标
主要结局
Time To Decompensation (TTDec)
时间窗: From index date to first hepatic decompensation/study completion, up to 30 months
time from index date (start of new treatment) to the first occurrence of events such as ascites of any grade according to the European Association for the Study of the Liver (EASL) classification, hepatic encephalopathy of any grade according to West Haven classification, variceal hemorrhage, or jaundice (total bilirubin \>3 mg/dL). In Child-Pugh (CP)-A participants with a score of 6 at index date, TTDec is defined as the time from index date to any worsening in ascites, hepatic encephalopathy, variceal hemorrhage, or jaundice (defined as an increase in total bilirubin to greater than 3 mg/dL or a worsening of more than 1.0 mg/dL from index date). At the time of decompensation (± 30 days) a CT scan should be performed to exclude worsening of liver function due to tumor progression.
次要结局
- Overall response rate (ORR)(From index date until objective tumor progression, assessed until study completion, up to 30 months)
- Progression free survival (PFS)(From index date until tumor progression, assessed until study completion, up to 30 months)
- Time To Worsening (TTWors)(Baseline and every 8 weeks during treatment, up to 30 months)
- Overall Survival (OS)(From index date through study completion, up to 30 months)
- Disease Control Rate (DCR)(From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months)
- Downstaging(From index date until study completion, up to 30 months)
- safety(From index date until study completion, up to 33 months)