Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Liver-specific overall response rate (ORR) according to RECIST 1.1
研究概览
简要总结
This real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (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 in China.
详细描述
This is a post-market trial evaluating the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Patients enrolled should already complete the infusion of SIR-Spheres® and data are about to be collected both retrospectively and prospectively. 200 patients are anticipated to be enrolled and followed up for up to 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Obtained informed consent for patients to be follow-up prospectively
- •Age≥18 years old
- •Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
- •Received SIR-Spheres®
排除标准
- •Special contraindications from package insert, which includes
- •Markedly abnormal liver function tests, such as total bilirubin > 2.0 mg/dL or albumin <3.0 g/dL
- •Portal vein thrombosis in the main trunk
- •Disseminated extrahepatic disease
- •Previous external beam radiation therapy to the liver
- •Women are lactating or pregnant during the study or plan to be pregnant during the study
- •Patients with mental illness or cognitive impairment
- •Per investigator, patients are non-adherent or reluctant to be followed up
结局指标
主要结局
Liver-specific overall response rate (ORR) according to RECIST 1.1
时间窗: 24 months
Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria
次要结局
- Overall survival (OS)(24 months)
- 1-yr OS(12 months)
- Progression-free survival(PFS) assessed by the investigator(24 months)
- Liver-specific PFS assessed by the investigator(24 months)
- ORR assessed by the investigator(24 months)
- Objective Duration of tumor response (DOR) assessed by the investigator(24 months)
- Duration of liver-specific DOR assessed by the investigator(24 months)