188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas (LIP-RE-I)

July 26, 2021 updated by: Center Eugene Marquis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Centre Eugène Marquis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rhenium Lipiodol
Hepatic Intra-Arterial Administration of radio-active lipiodol.
Drug: 188Re-SSS Lipiodol
Hepatic Intra-Arterial Administration of radio-active lipiodol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal tolerated dose
Time Frame: Injection each week during 4 weeks and at month 2
Toxicity CTC grade ≥ 3 with CTCAE version 4.
Injection each week during 4 weeks and at month 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bio-availability
Time Frame: 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.
1, 6, 24 et 48 hours after treatment injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Collaborators

Rennes University Hospital

Investigators

  • Principal Investigator: Etienne GARIN, MD, PhD, Centre Eugène Marquis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2010

Primary Completion (Actual)

August 6, 2019

Study Completion (Actual)

August 6, 2019

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIP-RE-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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