Special Drug Use Surveillance for Cabometyx Tablets "Hepatocellular Carcinoma"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets
研究概览
简要总结
This study is a survey in Japan of Cabozantinib tablets used to treat Japanese people with a type of liver cancer called hepatocellular carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with hepatocellular carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 12 months.
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
- •Participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (Regardless of previous treatment history)
排除标准
- •Participants who has a history of hypersensitivity to any component of cabozantinib.
研究组 & 干预措施
Cabozantinib 60 mg
Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets
时间窗: Up to 12 months
Number of Participants with Grade 3 or higher Adverse Events
时间窗: Up to 12 months
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis
时间窗: Up to 12 months
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Number of Participants with Serious Adverse Events
时间窗: Up to 12 months
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
次要结局
- Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Up to 12 months)
- Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)(Up to 12 months)
- Disease Control Rate (DCR)(Up to 12 months)
- Overall Survival (OS)(Up to 12 months)