Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Investigators 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 of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor 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, especially for the patients with high risk factors for residual tumor, such as tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion. 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. The main complications of TACE are liver function damage, mild feverish symptoms, vomit , etc. But most of them are reversible.
We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients with high risk factors for residual tumor (tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification.
- •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
- •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 doxorubicin or lipiodol
- •Pregnant woman
- •Informed consent not available
研究组 & 干预措施
TACE('Ethiodized Oil + Doxorubicin)
TACE using Ethiodized Oil + Doxorubicin mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4-6 weeks after surgery.
干预措施: Ethiodized Oil + Doxorubicin (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3 years after operation
次要结局
- Overall Survival(3-year after surgery)
- Complications of transarterial chemoembolisation(3-month after transarterial chemoembolisation)
研究者
Jia Fan
President of zhongshan hospital, Fudan University
Fudan University