A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- overall survival and treatment-related toxicity
研究概览
简要总结
The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for unresectable HCC.
详细描述
Transarterial therapy has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. Among the various options of transarterial therapy including chemoembolization (TACE), bland embolization, radioembolization, and TEA, chemoembolization is the only one that has been proven to be of survival benefits versus best supportive care in randomized controlled trials. TEA is a hybrid of bland embolization and chemical ablation. Utilizing a liquid agent of Lipiodol-ethanol mixture consisting of 33% ethanol by volume, TEA offers complete and long lasting embolization of both the arterioles and portal venules supplying the tumor and could possibly be more effective than particulate embolic agents in tumor vessel embolization. The component of ethanol very likely offers synergistic effect to embolization and causes tumor ablation.
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
- •Signed informed consent by patient
- •Age above 18 years
- •Child-Pugh A or B cirrhosis
- •Eastern Cooperative Oncology Group(ECOG) performance score 2 or below
- •No serious concurrent medical illness
- •No prior treatment or surgery for HCC
- •Histologically or cytologically proven HCC except for lesions of size 1 to 2 cm, with typical features of HCC on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with alpha feto protein(AFP) level > 200 ng/mL
- •Unresectable disease without extra-hepatic involvement on chest X-ray(CXR) and CT
- •Massive expansive tumor type with measurable lesion on CT
- •Total tumor mass < 50% liver volume
- •Tumor size ≤ 15cm in largest dimension
- •Tumor number ≤ 5
排除标准
- •History of prior malignancy except on the condition that the patient has been disease free for ≥ 3 years
- •Concurrent ischemic heart disease or heart failure
- •History of acute tumor rupture presenting with hemo-peritoneum
- •Serum creatinine level > 180 umol/L
- •Biliary obstruction not amenable to percutaneous drainage
- •Child-Pugh C cirrhosis
- •History of hepatic encephalopathy
- •Intractable ascites not controllable by medical therapy
- •History of variceal bleeding within last 3 months; serum total bilirubin level ≥ 50 umol/L
- •Serum albumin level < 25g/L
- •International normalized ratio(INR) > 1.5
- •Extrahepatic metastasis
- •Infiltrative or diffuse tumor
- •Tumor number > 5
- •Thrombosis of target hepatic artery
- •Partial or complete thrombosis of the main portal vein; tumor invasion of portal branch of contralateral lobe
- •Hepatic vein tumor thrombus
- •Significant arterio-portal venous shunt
- •Significant arterial-hepatic venous shunt
研究组 & 干预措施
Transarterial Ethanol Ablation (TEA)
Two treatment sessions at 2 months apart were given and started within 4 weeks after randomization.
干预措施: TEA (Procedure)
结局指标
主要结局
overall survival and treatment-related toxicity
时间窗: Overall survival is studied from treatment to death from any cause, for an estimated period of up to 60 months. Treatment-related toxicity is studied up to 3 months after treatment
Overall survival was defined as date of treatment to date of death from any cause. Patients alive at the end of follow-up were censored. Clinical and laboratory data were documented prospectively at baseline, during hospitalization, and at 7, 14, and 30 day, and 3, 6, 9, and 12 months. Laboratory findings were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.
次要结局
- Time to progression(TTP)(Time to progression is studied from treatment to disease progression, for an estimated period of up to 60 months.)
- Progression free survival(PFS)(Progression free survival is studied from treatment to disease progression or death from any cause, for an estimated period of up to 60 months.)
- Tumor response(Tumor response is studied at 6 months after treatment)
研究者
Simon Yu
Professor
Chinese University of Hong Kong