NCT01605734Unknown2 期
Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma
Shandong Cancer Hospital and Institute5 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Time to Progression
研究概览
简要总结
TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
- •BCLC stage B or C
- •Child-Pugh class score≤8
- •ECOG performance status ≤2
- •Etiology: Hepatitis B virus(HBV) infection
- •Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
- •Patient must be able to comply with the protocol
- •Age 18-75 years
- •Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
- •Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal，Prealbumin>0.5x the lower limit of normal.
- •Life expectancy of > 3 months
排除标准
- •BCLC stage D
- •Child-Pugh Score≥9
- •Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
- •Preexisting or history of hepatic encephalopathy
- •uncontrolled hypertension
- •Pregnancy (positive serum pregnancy test) or lactation
- •Serious, non-healing wound, ulcer, or bone fracture
- •Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
- •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
- •Other severe concomitant disease that may reduce life expectancy
- •Risk of allergic reactions to the study drugs
- •Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
研究组 & 干预措施
Group TACE
Active Comparator
TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated
干预措施: TACE (Procedure)
Group Combination
Experimental
All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
干预措施: sorafenib combined with TACE (Drug)
结局指标
主要结局
Time to Progression
时间窗: 1 year
Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week
次要结局
- FACT-Hep(six months)
- Disease control rate(six months after TACE)
- Safety(six months)
- PFS and OS(two years)
- Number of TACE sessions and the interval time between two TACE sessions(2 years)
- AFP(six months)
研究者
Jinlong Song
Chief, Division of Interventiolal Therapy
Shandong Cancer Hospital and Institute
研究点 (5)
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