Chemoembolization for Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
The aim of the current study is to study the safety and effectiveness of TACE using a high dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and it improves the therapeutic effect of conventional TACE.
详细描述
Most patients with HCC are diagnosed at an intermediate and advanced stage when the tumors become unresectable, transcatheter arterial chemoembolisation (TACE) has been widely accepted as a standard treatment for them in most international management protocols. The therapeutic effect of TACE in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. Internationally, high doses and combination of chemotherapeutic agents are being routinely and widely used for TACE in major medical centers. Locally, a low dose of cisplatin (10mg) has been used as the chemotherapeutic agent for TACE in Hong Kong. There is evidence showing that the component of chemotherapeutic agent in TACE does play a significant role in the treatment effect of TACE. In an attempt to improve the treatment effect of TACE, the investigators propose a formulation of TACE using a high dose of cisplatin as chemotherapeutic agent.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient factor
- •Child-Pugh A or B cirrhosis
- •ECOG performance status Grade 2 or below
- •No serious concurrent medical illness
- •No prior treatment for HCC except for liver resection
- •Creatinine clearance >55ml/min.
- •Tumor factor
- •HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
- •Unresectable and locally advanced disease without extra-hepatic disease
- •Massive expansive tumor type with measurable lesion on CT
- •Total tumor mass < 50% liver volume
- •Largest tumor of greatest dimension ≤ 15cm
排除标准
- •Patient factor
- •Serum creatinine level > 130 umol/L
- •Presence of biliary obstruction not amenable to percutaneous drainage
- •Child-Pugh C cirrhosis
- •Evidence of impaired liver function
- •History of hepatic encephalopathy, or
- •Intractable ascites not controllable by medical therapy, or
- •History of variceal bleeding within last 3 months, or
- •Serum total bilirubin level > 40 umol/L, or
- •Serum albumin level < 30g/L, or
- •Tumor factor
- •Presence of extrahepatic metastasis
- •Infiltrative lesion
- •Diffuse lesion
- •Vascular complications
- •Hepatic artery thrombosis, or
- •Partial or complete thrombosis of the main portal vein, or
- •Tumor invasion of portal branch of contralateral lobe, or
- •Hepatic vein tumor thrombus, or
- •Significant arterioportal shunt, or
- •Significant arteriovenous shunt
研究组 & 干预措施
TACE using a high dose of cisplatin
Two consecutive treatments at two months apart will be given. A delay in the second treatment is allowed if patients do not recover to an acceptable state for subsequent cycle of treatment. Two treatment sessions at one month apart may be required for each complete treatment to cover all lesions when the lesions are diffusely distributed and involving both lobes.
干预措施: TACE (Procedure)
TACE using a high dose of cisplatin
Two consecutive treatments at two months apart will be given. A delay in the second treatment is allowed if patients do not recover to an acceptable state for subsequent cycle of treatment. Two treatment sessions at one month apart may be required for each complete treatment to cover all lesions when the lesions are diffusely distributed and involving both lobes.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Tumor response
时间窗: 3 months after treatment
CT scan abdomen will be performed 3 months after the first treatment. Tumor response by CT was classified into complete response (CR), partial response (PR), static disease (SD, and progressive disease (PD) according to European Association for the Study of the Liver (EASL) necrosis guidelines,
次要结局
- overall survival(30 days after treatment)
研究者
Simon Yu
Professor
Chinese University of Hong Kong