Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge 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
- Overall Survival
研究概览
简要总结
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.
详细描述
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (>5cm in diameter) and huge HCC (>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.
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
- •Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;
- •Patients with large HCC (>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);
- •Patients with no thrombus in main portal vein (PV)
- •Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;
- •Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;
- •White blood cell count ≥ 3.0×10^9/L;
- •Hemoglobin ≥ 8.5g/dl;
- •Platelet ≥ 50×10^9/L;
- •INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;
- •Blood creatinine less than 1.5 times of upper limit of reference;
- •Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.
排除标准
- •Patients with diffuse type of liver cancer;
- •Cholangiocellular carcinoma
- •Patients with main PV thrombus;
- •Patients with hepatic vein thrombus;
- •Patients with lymph node or distant metastasis outside of liver;
- •Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;
- •Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;
- •Patients with intractable massive ascites;
- •Patients' ECOG PS >2;
- •Patients complicated with active infection, especially cholangitis;
- •Patients with severe disorders of heart, lungs, kidneys, or brain;
- •Patients and/or their relatives refuse to anticipate this study.
研究组 & 干预措施
Thermal Ablation & TACE
Transarterial chemoembolization (TACE) is performed immediately following thermal ablation.
EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Thermal Ablation (Procedure)
Thermal Ablation & TACE
Transarterial chemoembolization (TACE) is performed immediately following thermal ablation.
EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: EADM (Drug)
Thermal Ablation & TACE
Transarterial chemoembolization (TACE) is performed immediately following thermal ablation.
EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Ultra-fluid lipiodol (Drug)
Thermal Ablation & TACE
Transarterial chemoembolization (TACE) is performed immediately following thermal ablation.
EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Gelatin sponge articles (Other)
TACE alone
Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: EADM (Drug)
TACE alone
Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Ultra-fluid lipiodol (Drug)
TACE alone
Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Gelatin sponge articles (Other)
结局指标
主要结局
Overall Survival
时间窗: From the date of randomization until the date of death from any cause, assessed up to 26 months
次要结局
- Time-to-Disease Progression(From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months)
- Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups(From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation))
- Objective response rate (ORR)(Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.)
- Progression free survival(PFS)(From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months.)
- Numbers of TACE and TACE combined with ablation cycles(From the date of randomization until the date of death, assessed up to 26 months.)