NCT01352728已完成2 期
A Phase II Study of Transarterial Chemoembolisation and Axitinib for the Treatment of Unresectable Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Two-year survival rate
研究概览
简要总结
The survival of subjects with unresectable hepatocellular carcinoma (HCC) receiving transarterial chemoembolization is improved with addition of axitinib.
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
- •Histologically confirmed HCC (or fulfilling AASLD criteria for HCC diagnosis in HBsAg positive subjects with cirrhosis in case biopsy is not feasible)
- •Disease must not be amenable to potentially curative surgery
- •Without prior systemic nor transarterial treatment
- •Prior surgery or local therapy is allowed but the target lesion must have not been previously treated
- •Child-Pugh stage A liver function
- •ECOG performance 0-2
- •Life expectancy longer than 12 weeks
- •At least one measurable treatment lesion according to modified RECIST criteria
- •Adequate haematological, hepatic and renal function
排除标准
- •Contra-indications to TACE treatment:
- •Main portal vein thrombosis or occlusion
- •Evidence of biliary obstruction
- •Presence of extra-hepatic disease
- •Diffuse-type HCC
- •Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
- •Any form of prior transarterial therapy or systemic therapy for HCC.
- •Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers.
- •Requirement of anticoagulant therapy with oral vitamin K antagonists. Low dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
- •Any haemorrhage or bleeding event of CTCAE Grade 3 or more within 4 week
研究组 & 干预措施
TACE+Axitinib
Experimental
干预措施: Axitinib (Drug)
结局指标
主要结局
Two-year survival rate
时间窗: 4 years
次要结局
- Progression-Free Survival (PFS)(4 years)
- Overall survival (OS)(4 years)
- Time to Progression (TTP)(4 years)
- Duration of Response (DR)(4 years)
- Disease Control Rate (DCR)(4 Years)
- Overall confirmed objective response rate (ORR) as determined according to modified RECIST.(4 years)
- Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities(4 years)
- Quality of Life(4 years)
- Tissue and Serum Biomarkers(4 years)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
Loading locations...
相似试验
已完成
2 期
TACTICSHepatocellular carcinoma(HCC)Chemotherapy, Hepatocellular carcinoma(HCC), TACEJPRN-jRCTs031180074Kudo Masatoshi62
已完成
不适用
Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW ComparisonNon-metastatic Hepatocellular CarcinomaNCT04823715Hospices Civils de Lyon163
Unknown
2 期
TACE Plus HAIC With Oxaliplatin and Raltitrexed for BCLC Stage C HCCTransarterial ChemoembolizationHepatocellular CarcinomaNCT04597970Peking University Cancer Hospital & Institute66
终止
2 期
TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT00618384Heinrich-Heine University, Duesseldorf43
招募中
不适用
TACE-HAIC vs. HAIC for Potentially Resectable HCCPotentially ResectionHepatocellular CarcinomaNCT03591705Sun Yat-sen University240