NCT03727633招募中2 期
Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 7
- 主要终点
- Percentage of participants presenting a disease control at 4 months
研究概览
简要总结
The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking is used. All involved know the identity of the intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-proven HCC or according to EASL criteria
- •Child-Pugh A or B7
- •Disease that is not suitable for resection, ablation or radiofrequency
- •Performance Status ECOG 0 or 1
- •BCLC A/B or C if Performance Status ECOG = 1
- •Measurable lesions according to mRECIST criteria
- •No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation
- •Age superior or equal to 18 years
- •Platelets > 50,000/mm3, Polynuclear neutrophils > 1000/mm3, Creatininemia < 150umol/L, Bilirubinemia < 5 mg/dL
- •Absence of heart failure (Ultrasound LVEF > 50%)
- •Women of child-bearing age using an adequate method of contraception throughout treatment
- •Men using an adequate method of contraception throughout the treatment and at least 3 months after the end of treatment
- •Written informed consent
- •National health insurance cover
排除标准
- •Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
- •Large HCC with liver invasion >50%
- •History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose
- •Advanced liver disease (Child B8, B9 or C)
- •Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)
- •Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).
- •Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis)
- •Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)
- •Concomitant disease or uncontrolled severe clinical situation
- •Uncontrolled severe infection
- •Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
- •Pregnancy (Beta HCG positive) or breastfeeding
- •Patient who for psychological, social, family or geographical reasons cannot be followed regularly
- •Vulnerable person
- •Concomitant participation of the patient in another research involving the human person
研究组 & 干预措施
Treatment arm
Experimental
hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol
干预措施: Idarubicin and Lipiodol (Drug)
结局指标
主要结局
Percentage of participants presenting a disease control at 4 months
时间窗: 4 months
The primary outcome is to evaluate the disease control rate (partial, complete or stable response) 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.
次要结局
- Quality of life questionnaire (QLQ) QLQ-C30(12 months)
- Objective response rate of chemo-lipiodol(6 months)
- Safety of chemo-lipiodol defined by NCI-CTCAE version 4.03(12 months)
- best response at 6 months after the first cycle of chemo-lipiodol according to mRECIST(6 months)
- Overall survival(12 months)
研究者
研究点 (7)
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