Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study

Phase 1

Recruiting

Conditions: non-operable hepatocellular carcinoma
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-503341-60-00

Lead Sponsor: Centre De Lutte Contre Le Cancer Eugene Marquis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

Age = 18 year, ECOG Performance Status 0-1, Hepatocellular Carcinoma 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, Patient information and signature of informed consent or legal representative

Exclusion Criteria

Inadequate haematological, hepatic, renal, thyroid and coagulation functions: Haemoglobin < 8,5 g/dl, Granulocytes < 1500/mm3, Platelets< 50 000 /mm3, Bilirubin level = 35 µmol/l, Transaminases > 6 UNL, Creatinine > 1,5 UNL, TSH < 0.2 µUI/L, 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, Chronic respiratory insufficiency history, Extra-hepatic metastasis except hilum node < 2 cm, Lung shunt >20%, Poor tumor targeting, Previous SIRT, Previous systemic treatment for HCC within 4 weeks before radioembolization, More than 2 previous transcatheter arterial chemoembolization (TACE) (or embolization), in the area to be treated, Other neoplasia except if complete remission from at least one year