A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 602
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.
详细描述
The following abbreviations were used in the Adverse Event section:
- international normalized ratio (inr)
- Common Terminology Criteria for Adverse Events (ctcae)
- Not Otherwise Specified (nos)
- Gastrointestinal (gi)
- Central nervous system (cns)
- Absolute Neutrophil Count (anc)
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
- Creatine phosphokinase (cpk)
- Gammaglutamyltransferase (ggt)
- Genitourinary (gu)
- Atrioventricular (av)
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
- •Ages eligible for study: 18 years and above, Genders eligible for study: both
- •Patients who have a life expectancy of at least 12 weeks
- •Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
- •Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
- •Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2
排除标准
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted
- •Renal failure requiring hemo- or peritoneal dialysis
- •History of cardiac disease
- •Active clinically serious infections
- •Known history of human immunodeficiency virus (HIV) infection
- •Known central nervous system tumors including metastatic brain disease
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Placebo
Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time to Symptomatic Progression (TTSP)
时间窗: from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
TTSP was defined as the time from randomization to the first documented symptomatic progression.
次要结局
- Disease Control (DC)(time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment)
- Time to Progression (TTP)(from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment)
- Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire(from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment)