Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2) (Lip-Re2)
Hepatocellular Carcinoma Non-resectable
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Selective Internal Radiation Therapy, 188Re-SSS lipiodol
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 ECOG Performance Status 0-1 HCC with histological diagnosis or non-invasive diagnosis according to AASLD criteria Non operable and not accessible to ablation therapy At least one measurable lesion using mRECIST Tumor involvement <50% of the liver BCLC classification A to C Compensated cirrhosis (Child Pugh A or B7), if cirrhosis present Registration with a social security scheme Written and informed consent of the patient or his/her legal representative Exclusion Criteria: Inadequate hematological, hepatic, renal, thyroid and coagulation functions: Hemoglobin < 8,5 g/dl Granulocytes < 1500/mm3 Platelets< 50 000 /mm3 Bilirubin level ≥ 35 mol/l Transaminases > 6 UNL Creatinine > 1,5 UNL TSH < 0,2 µUI/L Chronic respiratory insufficiency history Extra-hepatic metastasis except hilum node < 2 cm Lung shunt >20% evaluated with 99mTc albumin macroaggregate (MAA) Poor tumor targeting with 99mTc albumin macroaggregate (MAA) Previous SIRT Previous systemic treatment within 4 weeks before radioembolization More than 2 previous TACE (or embolization), in the area to be treated Other neoplasia except if complete remission from at least one year Contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment Minors, individual deprived of liberty, or under any kind of guardianship or trusteeship. Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.
Sites / Locations
Arms of the Study
Arm 1
Experimental
188Re-SSS lipiodol SIRT
Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).