Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 845
- 试验地点
- 9
- 主要终点
- Liver PFS (LPFS)
研究概览
简要总结
This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres
详细描述
This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision.
The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Confirmed diagnosis of:
- •Unresectable hepatocellular carcinoma (HCC) Or
- •Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy
- •Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
- •Planned to receive SIR-Spheres treatment to the liver for the first time
- •Provision of signed patient informed consent
排除标准
- •Prior radiation treatment to the liver
- •Sequential selective internal radiation therapy (SIRT) treatment is allowed
- •Patients participating in any interventional clinical trial with an investigational product, device, or procedure
- •Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
结局指标
主要结局
Liver PFS (LPFS)
时间窗: 24months from LPI
Progression-free survival (PFS)
时间窗: 24months from LPI
Objective response rate (ORR) and liver response rate (LRR)
时间窗: 24months from LPI
Overall survival (OS)
时间窗: 24months from LPI
Duration of response (DoR)
时间窗: 24months from LPI
Change scores from baseline to follow-up timepoints of the EQ-5D-5L
时间窗: 24months from LPI
The (EurolQol) EQ-5D-5L is comprised of five questions on mobility, self-care, pain, usual activities, and psychological status with 5 level answers, 5 being extreme and 1 minimum.
Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30)
时间窗: 24months from LPI
The 30 EORTC QLQ-C30 items constitute consist of 9 domains: physical function, role function, cognitive function, emotional function, social function, fatigue, pain, nausea and vomiting, and global health status. Items are answered on a scale of 1 to 4 or 1 to 7.
Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Hepatocellular Carcinoma module (EORTC QLQ-HCC18)
时间窗: 24months from LPI
The EORTC QLQ-HCC18 instrument consists of 6 symptom scales and 2 single items: that measures fatigue, body image, jaundice, nutrition, pain, fever, sexual interest and abdominal swelling. Scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much').
次要结局
- Healthcare Resource Utilization summarized at follow-up timepoints(24months from LPI)
- SAEs/SADE's rates(24months from LPI)
- Subsequent hepatic procedures summarized at follow-up timepoints(24months from LPI)