Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver. Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall survival and time to progression.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- •Age ≥ 18 years and ≤ 80 years
- •At least one tumor nodule with one uni-dimension of ≥ 2 cm
- •Child-Pugh Class A or B
- •Total bilirubin ≤ 1.5 x upper limit of normal
- •ALT and AST ≤ 2.0 x the upper limit of normal
- •PT-INR<2.3,PTT < 1.5 x upper limit of normal
- •Serum creatinine ≤ 1.5x upper limit of normal
- •Peripheral white blood cell count of or more than 3×10(9)/L
- •Peripheral platelet of or more than 50×10(9)/L
- •Expected survival time not less than 3 months
- •ECOG score 0-2
排除标准
- •Tumor thrombi in main branch of portal vein
- •Tumor involvement more than 70% of whole liver
- •With extrahepatic metastasis
- •Prior systemic chemotherapy or chemoembolization
- •Congestive heart failure > NYHA class 2
- •History of HIV infection
- •Active clinically serious infections (> 2 NCI-CTC Version 3.0)
- •Recurrence of HCC after liver transplantation
- •Pregnant or breast-feeding
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
- •Known or suspected allergy to any agent given in association with this trial
- •Patients unable to swallow oral medication
- •Inclined to thrombosis
- •Inclined to hemorrhage or active hemorrhage with 1 month
研究组 & 干预措施
Thalidomide and TACE
Thalidomide is used for adjuvant therapy for TACE
干预措施: Thalidomide (Drug)
Thalidomide and TACE
Thalidomide is used for adjuvant therapy for TACE
干预措施: TACE (Drug)
TACE only
干预措施: TACE (Drug)
结局指标
主要结局
Overall survival
时间窗: 36 months
primary outcome is defined as overall survival. overall survival is calculated from the time of undergo treatment (TACE) to time of patients death.
次要结局
- time to progression(36 months)