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A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland

2026年8月12日 更新者：Takeda

FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients

Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.

The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.

Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.

The study will look at data already existing in the participants' medical charts.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

110

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

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

Eligible adult participants (aged 18 years and older) with mCRC who initiate treatment with fruquintinib under the national drug program (DP) (reimbursement program).

描述

Inclusion Criteria:

  1. Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride/tipiracil.
  2. Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.
  3. Participants for whom adequate medical records are available to support the data collection requirements.

Exclusion Criteria:

1. Participant currently participates or plans to participate in an interventional clinical trial.

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
Participants with mCRC
Adult participants with metastatic colorectal cancer (mCRC) who initiate treatment with fruquintinib under reimbursement program will be included. Participants will be observed for 12 months after treatment initiation, or until death.
其他：No intervention
No Intervention will be administered in this study.

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
Progression Free Survival (PFS)
大体时间：Up to 12 months
PFS as assessed by the Investigator is defined as the time from the first dose of fruquintinib until the first disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death for any reason. Participants without disease progression will be censored at the time of the last assessment of disease status.
Up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Up to 12 months
OS is defined as the time from the first dose of fruquintinib until death for any reason within the 12-month observation period or up the 12-month observation period whichever comes first. Participants will be censored at the time of the last assessment of survival status or day 365, if later survival status assessment is available.
Up to 12 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

Takeda

调查人员

  • 研究主任：Study Director、Takeda

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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 (估计的)

2026年8月20日

初级完成 (估计的)

2028年3月31日

研究完成 (估计的)

2028年3月31日

研究注册日期

首次提交

2026年5月29日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8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

  • TAK-113-4011

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

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD 共享访问标准

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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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