EUCTR2018-000740-25-IT进行中（未招募）1 期
TRANSARTERIAL EMBOLIZATION ALONE VERSUS DRUG-ELUTING BEADS CHEMOEMBOLIZATION FOR HEPATOCELLULAR CARCINOMA. A RANDOMIZED CONTROLLED TRIAL” - RAD-18-TAcE
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI0 个研究点目标入组 154 人开始时间: 2021年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •First-level eligibility criteria include:
- •1) diagnosis of HCC according to the AASLD criteria [26];
- •2) patients =18 years;
- •2) HCC unsuitable for curative treatment or for failure / recurrence after resection / ablation and diagnosed according to the AASLD criteria [26];
- •3) no previous treatment of target lesions (previous treatments include surgical resections on non-target lesions);
- •4) Child-Pugh Class A or B (maximum score 7);
- •5) ECOG Performance Status (PS) <2;
- •6) measurable target lesion according to mRECIST [24].
- •Second-level eligibility criteria include:
- •1) the prognostic score modified hepatoma arterial-embolization prognostic score (m-HAP-II) [27], based on bilirubin, albumin, alpha-fetoprotein, number of lesions and tumor size, which divides patients into 4 classes (A, B, C, D) with different survivals and is useful for stratifying the prognosis [28]. The first selection criteria will be the fulfillment of class B or C of m-HAP-II;
- •2) UNOS / TNM stage: patients with T1, T2, T3 and T4a will be included.
- •These two main criteria will be used for the stratification of patients before randomization in order to obtain an identical prevalence of the m-HAP-II B / C classes and of the UNO / TNM stages from T1 to T4a.
- •3) obtaining informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1) HCC infiltrative;
- •2) neoplastic invasion of a portal branch and of the common portal trunk;
- •3) equivocal liver injury;
- •4) advanced liver disease (bilirubin levels> 2.5 mg dl-1, albumin <30 g l-1, platelets <50 x 109 / L, INR> 1.5);
- •5) ascites and / or esophageal varices F3;
- •6) other tumors in the previous 5 years;
- •7) technical contraindications to arteriography or TACE.
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