A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- dose limiting toxicity
研究概览
简要总结
The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and TACE for unresectable HCC
详细描述
Most patients with Hepatocellular carcinoma (HCC) are diagnosed at an intermediate and advanced stage when the tumors become unresectable. Transcatheter arterial chemoembolization (TACE) has been shown to be effective in prolongation of survival for patients with unresectable HCC and generally adopted as a standard palliative treatment option for patients with intermediate stage HCC. However, 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. In many cases, patients with intrahepatic HCC uncontrolled after TACE treatment may not be suitable for other treatment options because of their physical condition. For these patients, repeat TACE combined with adjuvant systemic hyperthermia may offer a chance of disease control.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient factor
- •Age between 18 and 75
- •Child-Pugh A cirrhosis
- •Eastern Cooperative Oncology Group(ECOG) performance status Grade 2 or below
- •No serious concurrent medical illness
- •Prior treatment for HCC including surgery, local ablation, or transarterial treatments allowed
- •Imaging evidence of poor intralesional treatment response or disease progression despite transarterial treatment
- •Platelet count ≥ 50 10^9/L
- •Tumor factor
- •HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
- •Unresectable and locally advanced disease without extra-hepatic disease
- •Hypervascular lesions on CT
- •Greatest dimension of the largest tumor ≤15cm
排除标准
- •Patient factor
- •History of significant concurrent medical illness such as ischemic heart disease or heart failure
- •Metallic body implants, not including dental fillings
- •Serum creatinine level > 130 umol/L
- •Presence of biliary obstruction not amenable to drainage
- •Child-Pugh B or C cirrhosis
- •Unable to give consent
- •Evidence of impaired liver function
- •History of hepatic encephalopathy
- •Intractable ascites not controllable by medical therapy
- •History of variceal bleeding within last 3 months
- •Serum total bilirubin level >25 umol/L for the first 5 patients, serum total bilirubin level >35 umol/L for the second 5 patients
- •Serum albumin level < 30g/L
- •International normalized ratio(INR) >1.3
- •Tumor factor
- •Presence of extrahepatic metastasis
- •Infiltrative lesion
- •Vascular invasion
- •Hepatic artery thrombosis
- •Partial or complete thrombosis of the main portal vein
- •Tumor invasion of portal branch of contralateral lobe
- •Hepatic vein tumor thrombus
- •Significant arterioportal shunt
- •Significant arteriovenous shunt
- •Contraindication for hyperthermia
- •Known brain metastasis
- •Recent stroke or cerebral hemorrhage within last 6 months
- •Poorly controlled epilepsy
- •Poorly controlled cardiac arrhythmias
- •Myocardial infarction within last 6 months
- •Unstable angina within last 6 months
- •Poorly controlled hypertension
- •Poorly controlled diabetes
- •History of malignant hyperthermia
- •Photodermatosis
- •Pregnancy
- •Lactation
- •Serious infection
- •Grade 3 or above adverse event in serological total bilirubin or albumin according to Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events
- •Elevation of serum alanine transaminase ≥ 10 times upper limit of normal
研究组 & 干预措施
TACE with Hyperthermia treatment
Interventions: TACE to all liver lesions and two sessions of systemic hyperthermia performed at 24 hours and 48 hours respectively after TACE.
干预措施: TACE with Hyperthermia Treatment (Procedure)
结局指标
主要结局
dose limiting toxicity
时间窗: 30 days from the study treatment
次要结局
- treatment response by alphafetoprotein(6 months after treatment)
- adverse event of treatment(within 6 months of treatment)
- imaging evidence of objective tumor response(3 and 6 months after treatment)
研究者
Simon Yu
Professor
Chinese University of Hong Kong