NCT06190665招募中不适用
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
Zhongda Hospital2 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2023年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
研究概览
简要总结
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
详细描述
This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.
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
- •CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
- •ECOG PS score of 0-2
- •With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
- •Agree to participate in this trial and voluntarily sign the informed consent form
排除标准
- •Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
- •With diffuse liver tumor or extrahepatic metastasis, expected survival <6 months With sepsis or multiple organ dysfunction
- •Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine >2 mg/dL)
- •Significant reductions in white blood cells or platelets (white blood cells <3.0×10^9/L, platelets <50×10^9/L, hemoglobin<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by >3 seconds above the upper limit of normal)
- •With severe infection (>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
- •With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
- •Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
- •Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
- •Pregnant or lactating women
- •Patients who are participating in other trial(s)
- •Unsuitable for participation in this trial deemed by the researchers
结局指标
主要结局
Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
时间窗: 1 month after last TACE treatment
Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
次要结局
- Visualization score of embolic area(Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment)
- Disease control rate (DCR) for target lesions(1 month after the first TACE treatment, and 3 months after the last TACE treatment)
- Number of TACE treatments for target lesions(6 month since the last TACE treatment)
- Equipment performance evaluation(From the begin to immediately after each TACE treatment)
- Objective response rate（ORR）(1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment)
- Embolization success rate of target lesions(Immediately after each TACE treatment)
研究者
Gao-jun Teng
Dean
Zhongda Hospital
研究点 (2)
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