Systemic Chemotherapy VersusTranscatheter Arterial Chemoembolization As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Progression-Free-Survival
研究概览
简要总结
The purpose of this study is to determine that systemic chemotherapy is superior to transcatheter arterial chemoembolization in prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.
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
- 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
- •Eligible patients were age 18 to 75 years;
- •The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions.
- •ECOG score≤2;
- •life expectancy 3 months;
- •Barcelona Clinic liver cancer (BCLC) stage B or C disease;
- •Child-Pugh stage A or B disease;
- •Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin <1.5×ULN, international normalized ratio <1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT<5 ×ULN could be recruited if total bilirubin was in the normal range.
- •Patients had to provide signed informed consent to participate.
排除标准
- •documented allergy to lipoidal or other study drugs; any previous treatment before random assignment;
- •Previous liver transplantation;
- •concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
- •CNS metastasis;
- •Other serious illness or medical condition.
研究组 & 干预措施
systemic chemotherapy
Pirarubicin 30mg/m2 intravenously on Day 1 and Oxaliplatin 100 mg/m2 intravenously on Day 2 every 3 weeks until disease progression or limiting toxicity.
干预措施: Pirarubicin (Drug)
systemic chemotherapy
Pirarubicin 30mg/m2 intravenously on Day 1 and Oxaliplatin 100 mg/m2 intravenously on Day 2 every 3 weeks until disease progression or limiting toxicity.
干预措施: Oxaliplatin (Drug)
Transcatheter Arterial Chemoembolization
Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity.
干预措施: Pirarubicin (Drug)
Transcatheter Arterial Chemoembolization
Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity.
干预措施: Oxaliplatin (Drug)
Transcatheter Arterial Chemoembolization
Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity.
干预措施: Lipiodol (Drug)
Transcatheter Arterial Chemoembolization
Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity.
干预措施: Gelfoam (Device)
结局指标
主要结局
Progression-Free-Survival
时间窗: 3 months
次要结局
- Objective response rate(3 months)
- Time-to-Progression(3 months)
- Time-to-Progression within liver(3 months)
- Time-to-Progression outside the liver(3 months)
- Overall survival(6 months and 12 months)
研究者
Chengcheng Liao
Director, Principal Investigator, Clinical Professor
Guangxi Medical University