A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 732
- 主要终点
- Overall Survival
研究概览
简要总结
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.
详细描述
European quality of life scale (5 dimensions) (EQ-5D)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients > 18 years of age
- •Patients who have a life expectancy of at least 12 weeks
- •Patients with histological or cytologically documented HCC
- •Patients must have at least one tumor lesion that meets both of the following criteria:
- •The lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (RECIST)
- •The lesion has not been previously treated with local therapy
- •Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1
- •Cirrhotic status of Child-Pugh class A.
- •Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time.
排除标准
- •History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
- •Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren's syndrome) including congenital abnormality (e.g. Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).
- •History of interstitial lung disease (ILD).
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Previous treatment with yttrium-90 spheres
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- •Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)
Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)
Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
干预措施: Erlotinib (Tarceva) (Drug)
Sorafenib (Nexavar, BAY43-9006) + Placebo
Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Sorafenib (Nexavar, BAY43-9006) + Placebo
Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization of the first patient until 34 months or date of death of any cause whichever came first
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.
次要结局
- Disease Control(From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks)
- Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index(The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.)
- Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS(The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.)
- Time to Radiological Tumor Progression (TTP)(From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks)