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临床试验/NCT03349957
NCT03349957已完成不适用

Retrospective Study on TACE for HCC by TANDEM and Idarubicin

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年12月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
tumeur response

研究概览

简要总结

DcBeads and lipiodol-transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using doxorubicin result in about 50% objective response rate at 6 months (Precision V study, Lammer et al. CVIR 2010) We previously demonstrated that idarubicin was the most effective drug on 3 HCC cell lines (Boulin et al., Anticancer drugs 2009). We tested idarubicin-loaded beads in a phase I trial (Boulin et al., Aliment Pharmacol Therapy 2012) and more recently in a prospective multicentric phase II trial (IDASPHERE II, Magna Cum Laude CIRSE 2017, B Guiu et al.). This trial was stopped at interim analysis because the endpoint was reached.

Tandem beads are precisely calibrated, of small size, allowing the maximization of ischemic effects together with an optimal efficacy of the drug. We previously published that idarubicin was able to load fastly in Tandem, with minimal modification of bead diameter and a very interesting releasing profile of the drug (Guiu et al., JVIR 2015).

We used TANDEM combined with idarubicin in our practice for the treatment of HCC by TACE (in-label use of beads and the drug).

No clinical study (even retrospective) has been published so far with TANDEM-IDA (except our first paper published in JVIR in 2015, only 4 patients).

Here we propose to collect the retrospective data of patients treated by TANDEM-IDA, to help to design a future multicentric randomized phase II trial

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HCC according to histological examination or Barcelona criteria Measurable targets according to mRECIST v1.1 Child A or B7 cirrhosis (without decompensation in the past 6 months) HCC not candidate to surgery or ablation Age ≥ 18 years Performance status 0 or 1 Thrombocytes ≥ 50 000/mm3, neutrophil count≥ 1 000/mm3, creatininemia ≤ 150 µmol/L No cardiac failure

排除标准

  • Follow-up < 1month Lobar/main portal venous thrombus Prior treatment by systemic chemotherapy or radioembolization

结局指标

主要结局

tumeur response

时间窗: 1 day

tumeur response

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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