Hepatocellular carcinoma less than 3 cm treated with percutaneous tumour destruction: multicentric phase 2 trial assessing the impact of idarubicin-lipiodol intra-arterial chemotherapy on hepatic recurrence. - LIDA-ADJ

niversity Hospital of Montpellier0 个研究点目标入组 138 人开始时间: 2019年7月4日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•- Age = 18 years and = 80 years
•- Hepatopathy either histologically proven F3 or F4 stage, or with liver hardness measurements =10 kPa, either with suggestive morphological signs cirrhosis or portal hypertension viewed by medical Imaging
•- Child-Pugh score =B7
•- Patients with these biological parameters :
•platelets > 50 000/mm3
•neutrophils > 1000/mm3
•TP > 50%
•creatininemia < 150 µmol/L
•total bilirubinemia < 5 mg/dL
•a-fetoprotein < 200 ng/mL
•- WHO 0 or 1
•- unique and less than 3 cm hepatocellular carcinoma, with typical imaging characteristics as recommended by AASLD
•- patient with an indication of percutaneous tumoral destruction (radio frequency or microwave) under ultrasound or CT scan
•- Absence of heart failure (Left ventricular ejection fraction > 50%)
•- Woman of childbearing age using a method of contraception for the duration of treatment and at least 3 months after the end of treatment.
•- Man using a method of contraception for the duration of treatment and at least 3 months after the end of treatment.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Pregnancy (determination of positive ßHCG) or breastfeeding according to article L1121-5 of the CSP.
•- Presence on the initial imaging result of a macroscopic vascular invasion (portal or superhepatic vein).
•- Presence on the initial imaging result of non-hepatic locations of hepatocellular carcinoma.
•- Other non treated cancer
•- Contraindication to general anaesthesia
•- Contraindication to MRI Exploration
•- Hypersensitivity to anthracyclines, iodine or gadolinium.
•- Contraindication to injection of gadolinium-based contrast media
•- Contraindication to injection of iodine-based contrast media
•- Contraindication to idarubicin
•- Contraindication to Lipiodol
•- Patients who have already received or exceeded the recommended cumulative dose for anthracyclines (idarubicin = 150 mg/m²).
•- Failure of endoscopic elimination of esophageal varices with level >1.
•- Inability to accede to the protocol
•- Patient who for psychological, social, family or geographical reasons could not be followed regularly
•- Vulnerable persons according to Article L1121-6 of the CSP
•- Concurrent patient participation in another research involving the human person.
•- Non-affiliation with or no beneficiary of a social security scheme (Article L.1121-11).

发起方

niversity Hospital of Montpellier