Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- 1-year recurrence rate
研究概览
简要总结
We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. The aim of this study is to compare the survival of patients undergoing liver resection plus post-operative TACE versus liver resection alone.
详细描述
Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC patients received curative hepatectomy with negative resection margin
- •Age from 18 to 70
- •Child-Pugh class A
- •ASA class I to III
- •ECOG performance status Grade 0 or 1
排除标准
- •Patients receiving concomitant local ablation or previous TACE
- •Main portal vein tumour thrombus extraction during hepatectomy
- •Tumour arising from caudate lobe
- •Presence of extra-hepatic disease
- •Very early HCC with solitary tumour and size < 2cm
- •Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L
- •Renal impairment with creatinine > 200micromol/L
- •Severe concurrent medical illness persisting > 6 weeks after hepatectomy
- •History of other cancer
- •Hepatic artery anomaly making TACE not possible
- •Allergy to cisplatin or lipiodol
- •Pregnant woman
- •Informed consent not available
结局指标
主要结局
1-year recurrence rate
时间窗: 1-year after hepatectomy
The 1-year recurrence rate after hepatectomy in both arms of study were compared
次要结局
- Disease-free survival(5 years after operation)
- Overall Survival(5-year after surgery)
- Complications of transarterial chemoembolisation(3-month after transarterial chemoembolisation)
- Health-related quality of life assessment(1-year after surgery)
研究者
Cheung Yue Sun
Dr Cheung Yue Sun
Chinese University of Hong Kong