NCT01379521终止2 期
A Phase II Randomized, Double-blinded, Multicenter Asian Study Investigating the Combination of Transcatheter Arterial Chemoembolization (TACE) and Oral Everolimus (RAD001, Afinitor®) in Localised Unresectable Hepatocellular Carcinoma (HCC) - The TRACER Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP) Based on the Modified RECIST Criteria
研究概览
简要总结
This study will evaluate the role of everolimus in combination with local Transcatheter Arterial Chemoembolization (TACE) procedure in patients with localized unresectable Hepatocellular Carcinoma (HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Newly diagnosed hepatocellular carcinoma limited to liver and not suitable for resection, liver transplant, or radiofrequency ablation.
- •Intermediate stage (stage B) (according to recognized guidelines) and suitable for TACE therapy
- •At least one nodule between > 2cm and ≤ 15cm in diameter with no vascular invasion or abdominal lymph node or distant metastases.
- •Must have 1 tumor which can be measured in 1 dimension according to specified criteria (RECIST and mRECIST) and has not previously been treated with any type of therapy.
- •ECOG performance status < 2cm
- •Cirrhotic status of Child-Pugh class A or early B
- •HBV-DNA or HBsAg positive at screen or baseline: preventative treatment with anti-viral started 1-2 weeks prior to receiving study drug
排除标准
- •Any local and/or investigational drugs within 28 days prior to randomization
- •Active bleeding during the last 28 days prior to screening including variceal bleeding
- •Prior therapy with mTOR inhibitors
- •Tumor burden of > 60% liver involvement
- •Prior systemic or local therapy including TACE except for the first TACE at Day 0), surgery or liver transplantation
- •Failed first TACE at Day 0, Cycle 1 for any reason
- •Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
- •Alcohol intake of 80 grams per day
- •Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from surgery
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
everolimus + TACE
Experimental
everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
干预措施: everolimus (Drug)
placebo + TACE
Placebo Comparator
Placebo by mouth + transcatheter arterial chemoembolization (TACE)
干预措施: everolimus placebo (Drug)
结局指标
主要结局
Time to Progression (TTP) Based on the Modified RECIST Criteria
时间窗: 3, 6, 12, 18 and 24 months
Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on modified RECIST criteria. Progressive Disease: \>20% increase in sum of the longest diameters (SLD) of "viable" target lesion (arterial phase enhancement)
次要结局
- Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on the Modified RECIST(6, 12 months, end of study)
- Time to Progression Based on Original RECIST(6, 12 months, end of study)
- Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on Original RECIST(6, 12 months, end of study)
- Overall Survival (OS)(6, 12, 18, 24, 30 months)
- Incidences of Cumulative New Nodular Recurrence, Portal Vein Invasion and Extra Hepatic Metastases(30 months)
- Percentage of Participants With a Decrease in the Sum of the of Longest Diameters (SLD) of Target Lesions From Baseline to 30 Months(baseline, 30 months)
研究者
研究点 (1)
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