188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

Phase 1

Completed

• Conditions: Hepatocellular Carcinomas
• Interventions: Drug: 188Re-SSS Lipiodol

• Registration Number: NCT01126463
• Lead Sponsor: Center Eugene Marquis

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Study Start: 2010-05-26
• Primary Completion: 2019-08-06
• Study Completion: 2019-08-06
• Status Verified: 2020-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rhenium Lipiodol	188Re-SSS Lipiodol	Hepatic Intra-Arterial Administration of radio-active lipiodol.

Primary Outcome Measures

Name	Time	Method
Maximal tolerated dose	Injection each week during 4 weeks and at month 2	Toxicity CTC grade ≥ 3 with CTCAE version 4.

Secondary Outcome Measures

Name	Time	Method
Bio-availability	1, 6, 24 et 48 hours after treatment injection	Measurement by gamma-scintigraphy and by measurement of radio-activity in urinary, faecal and blood samples.

Trial Locations

Locations (1)

Centre Eugene Marquis; 🇫🇷 Rennes, France