The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).
详细描述
Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent.
Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.
Regimen 1: lipiodol combined chemotherapy with embolization
Regimen 2: lipiodol combined chemotherapy without embolization
Regimen 3: lipiodol single agent chemotherapy with embolization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult patients with minimal height of 150cm and minimal weight of 50 KG
- •Histological confirmed HCC
- •with no previous treatment
- •With unresectable tumor
- •With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
- •No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
- •No significant renal impairment (creatinine clearance < 30 mL/minute)
- •The following laboratory parameters:
- •Platelet count ≥ 60,000/µL
- •Hemoglobin ≥ 8.5 g/dL
- •Total bilirubin ≤ 1.5 mg/dL
- •ASL and AST ≤ 5 x upper limit of normal
- •Serum albumin ≥ 35 g/L
- •Serum creatinine ≤ 1.5 x upper limit of normal
- •INR ≤ 1.5 or a Pt/PTT within normal limits
- •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
- •Avascular tumor
- •Main portal vein obstruction without cavernous transformation
- •Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
- •Obstructive jaundice
- •Severe underlying cardiac or renal diseases
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Pregnant or breast-feeding patients.
- •History of organ allograft
- •Active clinically serious infections
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
结局指标
主要结局
Overall survival
时间窗: 3 years
次要结局
- Time to progression(3 years)
研究者
Shi Ming
Dr.
Sun Yat-sen University