NCT07607769招募中不适用
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)
适应症
干预措施
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
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)
研究者
研究点 (31)
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