Hepatic Resection Versus Transarterial Chemoembolization Plus Radiofrequency Ablation for Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 538
- 试验地点
- 3
- 主要终点
- overall survival
研究概览
简要总结
Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world. For patients with intermediate HCC (BCLC stage B), transarterial chemoembolization (TACE) has been recommended as the standard therapy in many clinical practice guidelines. The combination of TACE and radiofrequency ablation (RFA) has also been reported as an effective treatment. However, more and more retrospective studies have reported better therapeutic efficacy of hepatic resection than TACE for intermediate HCC. The purpose of this study was to compare the efficacy of hepatic resection versus TACE+RFA for the treatment of intermediate HCC through prospective randomized clinical trial.
详细描述
Barcelona Clinic Liver Cancer (BCLC) staging system is the most widely used stage classification for HCC management. For patients with intermediate HCC, palliative treatment transarterial chemoembolization (TACE) was recommended as first choice treatment. However, this recommendation remains controversial. The advice for diagnosis and treatment of HCC from former Chinese Ministry of Health indicated that BCLC may not be suitable in China as most HCC patients were found in intermediate or advanced stage. In recent years, more and more studies declared surgical resection as a better choice for HCC patients in BCLC stage B. However, lack of randomization, small sample size and lack of prospective studies limit the strength of evidence.
To solve this dilemma, a prospective randomized control study was performed to compare the efficacy (1-, 2-, 3-year survival) between surgical resection group and TACE plus radiofrequency ablation group in HCC patients in intermediate stage. This study will provide powerful evidence regarding the better treatment option for HCC patients in BCLC B stage, which will benefit the treatment efficacy of HCC patients in BCLC B stage.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular Carcinoma diagnosed by biopsy or imaging criteria (CT/MRI) and AFP
- •Signed informed consent before registration on study
- •Child-Pugh class A or B
- •Eastern Cooperative Oncology Group Performance status between 0 and
- •BCLC stage B ( diameter of the single tumor ≥5cm or number of tumors ≥3)
- •Hepatitis B history or HBsAg positive
- •Age between 18 and 65 years
- •No previous treatment
- •Laboratory examination test: Platelet count ≥100×109/L; ALT/AST ≤ 3 x ULN; Cr1.5≤ x ULN; INR < 1.5 or PT< ULN +4s; Alb≥30g/L; Tbil≤34mmol/L
- •For patients in Hepatic resection group: radical surgery will be performed: (1) No segmental, lobar or main portal vein and bile duct thrombosis; (2) no lymph nodes metastasis; (3) no extra hepatic metastasis.
排除标准
- •cachexia or poor physical condition;
- •pregnant or HCG positive;
- •Portal vein and bile duct thrombosis or with extra hepatic metastasis.
- •Uncontrolled or refractory ascites or history of hepatic encephalopathy
- •Severe heart, brain or kidney diseases
- •hemophilia or patients with coumarin derivative therapy.
- •.history of organ transplantation or mental disease.
- •Be allergic to adriamycin, lobaplatin, mitomycin or iodized oil
结局指标
主要结局
overall survival
时间窗: 3 years
compare 3-year overall survival between the two arms
次要结局
- disease free survival(3 years)
研究者
Baogang Peng
Director, Department of Hepatic Surgery
First Affiliated Hospital, Sun Yat-Sen University