TheranosticTrials.org

Clinical Trial · NCT01126463

188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

Overview

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.

Sponsor

Centre Eugène Marquis

Phase

Phase 1

Contacts

Etienne GARIN, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01126463

Drug / Compound

SSS Lipiodol

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Adult over 18,
  • 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,
  • WHO performance status ≤ 2,
  • Possibility of treatment by intra-arterial radiotherapy over a decision of a Multidisciplinary Committee,
  • 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,

Exclusion

  • Grade III Hepatocarcinoma of the Okuda classification
  • Pregnant or breastfeeding woman, or not using adequate effective contraception method
  • Patients who can't be followed up for psychological or geographic reasons
  • Contraindication to the intra-arterial administration
  • Advanced chronic respiratory insufficiency
  • Patients dependant on another person for daily care
  • Patient with a stage ≥ 3 toxicity of the CTCAE version 4
  • Progressive cancer
  • Stage D of the classification BCLC
  • Acute impairment of hepatic functions (Child-Pugh B9 or C)
  • Encephalopathy with troubles even moderated of cognitive functions
  • Urinary incontinence
  • Creatinine clearance \< 55 ml/min, polynuclear neutrophils \< 1500 G/L, platelets \< 50 G/L, prothrombin \< 40% (INR \> 2,3)