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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. (MONTEROSA)

2026年8月26日 更新者：AstraZeneca

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)

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
  • 电话号码：9479 +1877240
  • 邮箱：information.center@astrazeneca.com

学习地点

  • 意大利
      • Ancona、意大利、60126
        • 主动，不招人
        • Research Site
      • Bergamo、意大利、24129
        • 主动，不招人
        • Research Site
      • Foggia、意大利、71122
        • 招聘中
        • Research Site
      • Meldola、意大利、47014
        • 主动，不招人
        • Research Site
      • Milan、意大利、20162
        • 主动，不招人
        • Research Site
      • Milan、意大利、20122
        • 主动，不招人
        • Research Site
      • Modena、意大利、41124
        • 主动，不招人
        • Research Site
      • Naples、意大利、80131
        • 招聘中
        • Research Site
      • Padova、意大利、35100
        • 主动，不招人
        • Research Site
      • Palermo、意大利、90127
        • 主动，不招人
        • Research Site
      • Pisa、意大利、56126
        • 主动，不招人
        • Research Site
      • Pozzuoli、意大利、80078
        • 主动，不招人
        • Research Site
      • Roma、意大利、00168
        • 主动，不招人
        • Research Site
      • Rozzano、意大利、20089
        • 主动，不招人
        • Research Site
      • Torino、意大利、10126
        • 主动，不招人
        • Research Site
      • Verona、意大利、37134
        • 主动，不招人
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population will be made up of patients with histologically or radiologically confirmed advanced or uHCC not amenable to surgery and/or locoregional therapies, and without previous systemic therapy for HCC who are starting treatment with STRIDE as per routine clinical practice and independently of participation in this study. The study aims to enroll approximately 200 patients.

描述

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
aHCC/uHCC
patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice.
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time To Decompensation (TTDec)
大体时间：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.
From index date to first hepatic decompensation/study completion, up to 30 months

次要结果测量

结果测量
措施说明
大体时间
Time To Worsening (TTWors)
大体时间：Baseline and every 8 weeks during treatment, up to 30 months
Time To Worsening (TTWors) based on the EORTC QLQ-C30 and QLQ-HCC18 PROs within the first 18 months of treatment. TTWors is the time from first treatment to first clinically meaningful deterioration confirmed at a subsequent visit/assessment or death from any cause. A clinically meaningful change (deterioration or improvement) is defined as an absolute change ≥ 10 points in total score from index date.
Baseline and every 8 weeks during treatment, up to 30 months
Overall Survival (OS)
大体时间：From index date through study completion, up to 30 months
time from first treatment to death
From index date through study completion, up to 30 months
Progression free survival (PFS)
大体时间：From index date until tumor progression, assessed until study completion, up to 30 months
time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1).
From index date until tumor progression, assessed until study completion, up to 30 months
Overall response rate (ORR)
大体时间：From index date until objective tumor progression, assessed until study completion, up to 30 months
proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1.
From index date until objective tumor progression, assessed until study completion, up to 30 months
Disease Control Rate (DCR)
大体时间：From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
proportion of participants with a CR, PR, or stable disease (SD) per RECIST v1.1. (stable disease needs to be maintained for a minimum of 8 weeks to be included in the DCR).
From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months
Downstaging
大体时间：From index date until study completion, up to 30 months
Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen
From index date until study completion, up to 30 months
safety
大体时间：From index date until study completion, up to 33 months
Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome.
From index date until study completion, up to 33 months

其他结果措施

结果测量
措施说明
大体时间
TTDec subgroups
大体时间：From index date to first hepatic decompensation/study completion, up to 30 months

defined for the primary outcome within the first 18 months of treatment by:

• Baseline ALBI grade (1 vs 2 or 3)

• Cirrhosis at baseline (yes vs no)

• Signs of portal hypertension at baseline, i.e., splenomegaly and thrombocytopenia and presence of collateral circulation, or porto-systemic shunts (yes vs no)
From index date to first hepatic decompensation/study completion, up to 30 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月16日

初级完成 (估计的)

2028年10月31日

研究完成 (估计的)

2028年10月31日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • D419CR00060

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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