跳至主要内容
临床试验/NCT07607769
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)

AstraZeneca31 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年4月16日最近更新:
适应症
干预措施
相关药物

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
观察性
观察模型
队列研究
时间视角
前瞻性

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 1.
  • 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)

研究者

发起方
AstraZeneca
申办方类型
企业
责任方
申办方

研究点 (31)

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标识符

NCT 编号
NCT07607769
其他研究编号
D419CR00060

日期

首次提交
(5个月前)
首次发布
(4个月前)
主要完成日期
(2年后)
研究完成日期
(2年后)
最近核实
(6个月前)
最近更新
(昨天)

监管与共享

FDA 监管药物
是
FDA 监管器械
否
个体参与者数据共享计划
是

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

是否有结果
否

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