A Phase II Study to Evaluate the Safety, Tolerability and Efficacy of Cabozantinib in Patients With Hepatocellular Carcinoma (HCC) and Impaired Liver Function (Child-Pugh Score B7-8)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Blood pressure [Safety and Tolerability]
研究概览
简要总结
This is an prospective, interventional, non-randomized multicenter phase II study to evaluate the safety, tolerability and efficacy of Cabozantinib as a second-line therapy (after one prior systemic therapy) in patients with intermediate to advanced HCC (BCLC B/C) and concomitant impaired liver function CP score B7-8. Subjects who meet all study eligibility criteria will receive Cabozantinib 40 mg daily orally. Subjects will receive Cabozantinib as long as they continue to experience clinical benefit in the opinion of the Investigator or until there is unacceptable toxicity or the need for subsequent systemic anti-cancer treatment or liver directed local anti-cancer therapy. Treatment may continue in this fashion after radiographic progression as long as the Investigator believes that the subject is still receiving clinical benefit from Cabozantinib and that the potential benefit of continuing Cabozantinib outweighs potential risk. In addition, all subjects will be treated with best supportive care. This excludes systemic anti-cancer therapy and liver-directed local anti-cancer therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cabozantinib
40 mg cabozantinib oral daily. When dose reduction is necessary, it is recommended to reduce to 20 mg daily.
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Blood pressure [Safety and Tolerability]
时间窗: Through study completion, up to approximately 2 years.
mmHg
Incidence of Adverse Events (AEs) [Safety and Tolerability]
时间窗: Through study completion, up to approximately 2 years
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs) [Safety and Tolerability]
时间窗: Through study completion, up to approximately 2 years
The number of participants who discontinue study treatment due to an AE will be presented.
ALBI [Safety and Tolerability]
时间窗: Through study completion, up to approximately 2 years
Assessment of the Albumin-Bilirubin (ALBI) Grade. Grade range 1-3, with 3 indicating greatest severity
ECOG [Safety and Tolerability]
时间窗: Through study completion, up to approximately 2 years
Eastern Cooperative Oncology Group (ECOG) performance status. Score range 0 (normal activity) to 5 (dead).
Child-Pugh [Safety and Tolerability]
时间窗: Through study completion, up to approximately 2 years
Used to assess the prognosis of chronic liver disease. Classification of severity of liver disease according to the degree of ascites, total bilirubin and albumin, prothrombin time, and degree of encephalopathy. Each measure is scored 1-3, with 3 indicating greatest severity
次要结局
- Overall survival (OS)(Through study completion, up to approximately 2 years)
- Progression-free survival (PFS)(Through study completion, up to approximately 2 years)
- Objective response rate (ORR)(Through study completion, up to approximately 2 years)
- Pharmacokinetics (PK) of Cabozantinib administration.(6 weeks)
- Health-related quality of life (HRQOL)(Through study completion, up to approximately 2 years)
研究者
Marcus-Alexander Wörns
Senior consultant, Department of Internal Medicine I
Johannes Gutenberg University Mainz