Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study
Key facts
- Where
- Rennes Cedex, FranciaországSee the site
- Phase
- 2. fázis
Where in Franciaország
- Centre De Lutte Contre Le Cancer Eugene MarquisRennes Cedex, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Trial code
- EU 2023-503341-60-00
- Record updated
- 2025. november 6.
- Original description
To evaluate the efficacy of 188Re-SSS lipiodol Selective Internal Radiation Therapy in non-operable hepatocellular carcinomaRead full original descriptionShow less
To evaluate the efficacy of 188Re-SSS lipiodol Selective Internal Radiation Therapy in non-operable hepatocellular carcinoma
Inclusion: 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 only), if cirrhosis present; Patient information and signature of informed consent or legal representative.
Exclusion: 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; Chronic respiratory insufficiency history; 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; Lung shunt >20%; Poor tumor targeting; Ascites (even if only radiological); 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; 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; Know hemophilia with exophytic tumor > 1 cm; Extra-hepatic metastasis except hilum node < 2 cm.