188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

NCT ID: NCT01126463

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-26
• Study Completion Date: 2019-08-06

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.

Conditions

Hepatocellular Carcinomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rhenium Lipiodol

Hepatic Intra-Arterial Administration of radio-active lipiodol.

Group Type: EXPERIMENTAL

188Re-SSS Lipiodol

Intervention Type: DRUG

Hepatic Intra-Arterial Administration of radio-active lipiodol.

Interventions

188Re-SSS Lipiodol

Hepatic Intra-Arterial Administration of radio-active lipiodol.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: collaborator

Center Eugene Marquis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne GARIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Eugene Marquis

Locations

Centre Eugene Marquis

Rennes, , France

Countries

France

References

Garin E, Rakotonirina H, Lejeune F, Denizot B, Roux J, Noiret N, Mesbah H, Herry JY, Bourguet P, Lejeune JJ. Effect of a 188 Re-SSS lipiodol/131I-lipiodol mixture, 188 Re-SSS lipiodol alone or 131I-lipiodol alone on the survival of rats with hepatocellular carcinoma. Nucl Med Commun. 2006 Apr;27(4):363-9. doi: 10.1097/00006231-200604000-00008.

Reference Type: BACKGROUND

PMID: 16531923 (View on PubMed)

Other Identifiers

LIP-RE-I

Identifier Type: -

Identifier Source: org_study_id