The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Compared With Transarterial Chemoembolization as Initial Treatment in Patients With Large Hepatocellular Carcinoma Staged BCLC A/B.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large hepatocellular carcinoma staged BCLC A/B.
详细描述
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma staged BCLC A/B especially for those with tumor larger than 10 cm. Our previous prospective study also revealed similar results of large HCC patients treated with TACE. Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of HAIC over TACE.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18-75 years;
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system.
- •Patients must have at least one tumor lesion that can be accurately measured;
- •The sum of diameters of all lesions longer than 10 cm with the maximum lesion longer than 7 cm.
- •Diagnosed as unresectable with consensus by the panel of liver surgery experts;
- •Re commanded treated by TAI or TACE with consensus by the panel of liver MDT;
- •No past history of TACE, TAI, chemotherapy or molecule-targeted treatment;
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL;(b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits;(h) Absolute neutrophil count (ANC) >1,500/mm3;
- •Ability to understand the protocol and to agree to and sign a written informed consent document.
排除标准
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Evidence of bleeding diathesis.
- •Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
- •Serious non-healing wound, ulcer, or bone fracture
- •Known central nervous system tumors including metastatic brain disease
- •Poor compliance that can not comply with the course of treatment and follow up.
研究组 & 干预措施
Hepatic arterial infusion chemotherapy
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
干预措施: Hepatic arterial infusion chemotherapy (Procedure)
Hepatic arterial infusion chemotherapy
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
干预措施: Folfox Protocol (Drug)
Transarterial chemoembolization
Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, with or without MMC), and embolization with polyvinyl alcohol particles (PVA).
干预措施: Transarterial chemoembolization (Procedure)
Transarterial chemoembolization
Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, with or without MMC), and embolization with polyvinyl alcohol particles (PVA).
干预措施: TACE Drug Protocol (Drug)
结局指标
主要结局
Overall survival
时间窗: 24 months
次要结局
- Number of of Patients developed Adverse Events(30 Days after HAIC)
- Time to progression(24 months)
- Adverse Events(30 Days after HAIC)
研究者
Shi Ming
Proffessor
Sun Yat-sen University