Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization(TACE) for Huge Unresectable Hepatocellular Carcinoma: a Multicenter Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this study was to prospectively evaluate the efficacy and safety of TACE combined with MWA in patients with huge unresectable hepatocellular carcinoma.
详细描述
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide. Despite the widespread application of surveillance programs in high-risk populations, patients continue to present with huge (≥ 10 cm) HCCs.And it's still a challenge to treat huge HCC nowadays.Surgical resection is currently the only curative treatment for huge HCCs ; however, only a minority of patients are candidates for curative resection. Sorafenib is recommended for the treatment of advanced HCCs, including huge HCCs, but the usage is severely limited by high adverse event rates and low efficiency. Thus, transarterial chemoembolization (TACE) is considered the first choice for huge unresectable HCCs. Several studies have concluded that TACE effectively improves the overall survival of patients with huge HCCs. Meanwhile, microwave ablation (MWA) now has been shown to be safe and effective for local tumor control in HCC patients. However, neither MWA nor TACE alone can achieve complete control of large HCCs . Therefore, the combination of TACE and MWA (TACE+MWA) is an appealing approach to treat HCCs. TACE+MWA now has been shown to improve overall survival rates compared with TACE alone in patients with small to large HCCs. But little data is available on TACE+MWA in patients with huge unresectable HCCs. Thus, the study was designed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The performance status of Eastern Cooperative Oncology Group (ECOG) must be 0-1
- •The diagnosis of primary hepatocellular carcinoma must be in line with the American Society for the study of liver diseases (AASLD) diagnostic criteria for hepatocellular carcinoma (HCC)
- •Child-Pugh score A or B;
- •Aged from 18 to 75 years;
- •Subjects voluntarily join the study, and signe informed consent;
- •No anti-tumor therapy was received；
- •Meet the following 4 characteristics: A. primary tumor diameter more than or equal to 10cm; B. no more than 3 HCC foci, and the maximum diameter is less than or equal to 5cm; C. with IIa, I or no portal vein tumor thrombus (Cheng's Classification)；D. the tumor could not be surgically removed
- •No extrahepatic metastases
排除标准
- •Abnormal coagulation function: PLT < 40×109/L, PTA < 40%;
- •Patients have the past history of liver cancer treatment, such as transplantation, resection, radiotherapy, chemotherapy and so on;
- •Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- •Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
- •Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
- •Patients accompanied with other tumors or past medical history of malignancy;
- •Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
- •Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol;
- •Patients have poor compliance.
研究组 & 干预措施
TACE+MWA
Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
干预措施: TACE (Procedure)
TACE+MWA
Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
干预措施: MWA (Procedure)
TACE+MWA
Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
干预措施: MWA system (Device)
TACE+MWA
Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
干预措施: Chemoembolization (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: up to 3 years
Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
次要结局
- Progression-free survival (PFS)(up to 3 years)
- Adverse event rate(up to 3 years)
- Distant metastasis-free survival(up to 3 years)
研究者
Fan Weijun
the professor of Sun Yat-sen University
Sun Yat-sen University