Specific Use-results Study of IMJUDO Intravenous Infusion 25 mg, 300 mg / IMFINZI Intravenous Infusion 120 mg, 500 mg All Patient Investigation in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Incidence of ADRs
研究概览
简要总结
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting.
详细描述
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting.
The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who receive IMJUDO and IMFINZI combination therapy or IMFINZI monotherapy for their unresectable HCC.
排除标准
- 未提供
结局指标
主要结局
Incidence of ADRs
时间窗: 24 weeks
次要结局
未报告次要终点
