188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

• Status: Completed
• Trial end date: 2019-08-06
• Target enrollment: 0
• Participant gender: All

Summary

This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center Eugene Marquis
• Collaborators: Ecole Nationale Superieure de Chimie de Rennes; Rennes University Hospital
• Treatments: Ethiodized Oil

Criteria

Inclusion Criteria:

• Adult over 18,

• WHO performance status ≤ 2,

• Hepatocellular carcinoma histologically or cytologically proven, or association of liver tumor with chronic hepatopathy and AFP > 400 ng/ml, or tumorous hepatic formation considered as hypervascularised by at least 2 methods of imaging in cirrhotic patient, Non operable, non resectable, non transplantable, non accessible to percutaneous treatment tumor,

• Measurable tumor, uni- or multinodular, taking up less than 50% of hepatic volume,

• Stage A to C of the BCLC classification (or stage 0 to 4 of the CLIP) with:

• No thrombosis of the portal vein, therapeutic escape or intolerance causing the end of the treatment or contraindication to sorafenib

• If thrombosis of the portal vein, therapeutic escape to Lipiocis,

• Possibility of treatment by intra-arterial radiotherapy over a decision of a Multidisciplinary Committee,

• Written informed consent

Exclusion Criteria:

• Patient with a stage ≥ 3 toxicity of the CTCAE version 4

• Stage D of the classification BCLC

• Acute impairment of hepatic functions (Child-Pugh B9 or C)

• Grade III Hepatocarcinoma of the Okuda classification

• Encephalopathy with troubles even moderated of cognitive functions

• Advanced chronic respiratory insufficiency

• Creatinine clearance < 55 ml/min, polynuclear neutrophils < 1500 G/L, platelets < 50 G/L, prothrombin < 40% (INR > 2,3)

• Contraindication to the intra-arterial administration

• Patients who can't be followed up for psychological or geographic reasons

• Patients dependant on another person for daily care

• Urinary incontinence

• Progressive cancer

• Pregnant or breastfeeding woman, or not using adequate effective contraception method