NCT04619329Unknown不适用
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm): A Single Center, Open, Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Median Overall Survival (mOS)
研究概览
简要总结
A Single center, Open, Randomized Controlled Trial Evaluating the Safety and Efficacy of GSMs-TACE combined with Surgical Resection in Treatment of Huge Hepatocellular Carcinoma (HCC) (≥10cm).
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
- •Confirmed imaging and pathological diagnosis of HCC, or diagnosed for the first time according to the guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition).
- •Barcelona Clinic Liver Cancer (BCLC) stage A or B.
- •Remnant liver volume and liver function reserve are suitable for surgical resection.
- •Main lesion diameter ≥10cm.
- •Number of HCC lesions ≤5 and all located on one liver lobe.
- •Liver function Child-Pugh class A
- •ECOG Performance Status 0-1
- •Life expectancy ≥ 6 months
- •HCC is diagnosed for the first time.
- •Age 18 to 75 years
- •Able to sign and provide written informed consent.
排除标准
- •Severe active infection >grade 2 (except for Hepatitis B and C infection).
- •Liver function Child-Pugh class C.
- •BCLC stage C.
- •Patients with unresectable HCC.
- •Platelet <60×109/L.
- •Concomitant malignant tumors in other organs.
- •Patient with severe cardiac, lung or kidney disease, or severe diabetes.
- •Pregnant or breast-feeding woman.
- •Patients with severe neuropathy and unable to report therapeutic effects.
- •Patients with severe atherosclerosis.
- •Patients with AIDS.
- •Severe hemorrhage of digestive tract within the 4 weeks prior to enrolment.
- •Severe thrombogenesis or embolic event within the 6 months prior to enrolment.
- •Currently enrolled or going to enroll in any other clinical trials.
- •Subject is not suitable to participate in the study as judged by investigator (poor patient compliance，inability to follow up).
研究组 & 干预措施
GSMs-TACE+ Surgical Resection Group
Experimental
After TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol.
干预措施: GSMs-TACE (Device)
GSMs-TACE+ Surgical Resection Group
Experimental
After TACE using Lobaplatin and GSMs (150-350μm, 350-560μm, 560-710μm or 710-1000μm), patients will receive surgical resection 15-30 days later, as specified per protocol.
干预措施: Surgical Resection (Procedure)
Surgical Resection Group
Active Comparator
Patients will receive surgical resection, as specified per protocol.
干预措施: Surgical Resection (Procedure)
结局指标
主要结局
Median Overall Survival (mOS)
时间窗: 2 years
Disease Free Survival（DFS）
时间窗: 6 months
次要结局
- Adverse Events(6 months)
- Incidence of Intrahepatic Metastasis(6 months)
- Overall Survival (OS)(1 and 2 years)
- Incidence of Extrahepatic Metastasis(1 and 2 years)
研究者
研究点 (1)
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