NCT04619342Unknown不适用
Safety and Efficacy of GSMs-TACE Combined With Surgical Resection in the Treatment of Hepatocellular Carcinoma (HCC) With Type III Portal Vein Tumor Thrombus (PVTT): A Single Center, Open, Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Progression Free Survival（PFS）
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 the Treatment of Hepatocellular Carcinoma (HCC) with Type III Portal Vein Tumor Thrombus (PVTT).
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 diagnosis of HCC with PVTT involving the main portal vein, i.e. Type III PVTT according to Cheng's classification.
- •Confirmed abundant blood supply of tumor thrombus using Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).
- •The tumor must be surgically resectable.
- •ECOG Performance Status 0-
- •Adequate liver function (Child-Pugh class A)
- •Life expectancy ≥ 3 months
- •Previous physical ablation is allowed.
- •Age 18 to 75 years
- •Able to sign and provide written informed consent.
排除标准
- •Patients previously took oral molecular targeted drug or received immunotherapy.
- •Patients with arteriovenous fistula.
- •Severe active infection >grade 2 (except for Hepatitis B and C infection).
- •Concomitant malignant tumors in other organs.
- •Presence of severe cardiac, lung or kidney disease.
- •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).
结局指标
主要结局
Progression Free Survival（PFS）
时间窗: 6 months
PFS is defined as the time from Day 1 of treatment until the progression of a target lesion or the appearance of new lesions.
次要结局
- Overall Survival(3, 6, 12 and 18 months)
- Adverse Events(6 months)
- Median Overall Survival (mOS)(2 years)
研究者
研究点 (1)
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