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Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

Phase 1
18 Years
Open (Enrolling)
Hepatocellular Carcinomas

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Trial Information

Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

Hepatocellular carcinoma is one of the most prevalent primary cancers in many countries. In
France, mortality due to HCC on viral C cirrhosis is going to increase of about 150% for men
and 200% for women until 2020. Consequently, HCC is a problem of public health.

The current treatment for HCC is mainly palliative with chemoembolization or intra-arterial
radiotherapy, and intra-arterial targeted radiotherapy being the best tolerated method
(iodine-131-labelled lipiodol being the most commonly used).

However, since 2007, a new therapeutic approach can be considered with oral sorafenib, an
anti-angiogenic drug which increases slightly the survival of patients.

The key for an efficient treatment of HCC is presumably a co-treatment of sorafenib and
intra-arterial radiotherapy. The 131I-lipiodol is a good candidate but presents
disadvantages: it requires hospitalization in a radionuclide therapy room for one week.
Therefore, it is necessary to find new radioactive labellings for lipiodol. In this
objective, 188Re-SSS lipiodol, a new radioactive labeled stable complex has been developed.
It has a short half-life and a tiny amount of gamma radiation compared to 131I-lipiodol, so
it allows to reduce hospitalization in a protected room from 8 days to only one day.

The aim of this study is to determine the Maximum Tolerated Dose and thus the recommended
activity of 188Re-SSS lipiodol by intra-arterial injection in patients with HCC.

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal tolerated dose

Outcome Description:

Toxicity CTC grade ≥ 3 with CTCAE version 4.

Outcome Time Frame:

Injection each week during 4 weeks and at month 2

Safety Issue:


Principal Investigator

Etienne GARIN, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Eugene Marquis


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

May 2010

Completion Date:

May 2012

Related Keywords:

  • Hepatocellular Carcinomas
  • Hepatocellular carcinomas
  • lipiodol
  • rhenium
  • Non operable Hepatocellular carcinomas
  • Carcinoma
  • Carcinoma, Hepatocellular