Back to results188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas (LIP-RE-I)
Primary Purpose
Hepatocellular Carcinomas
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
188Re-SSS Lipiodol
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinomas focused on measuring Hepatocellular carcinomas, lipiodol, rhenium, Non operable Hepatocellular carcinomas
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
Sites / Locations
- Centre Eugene Marquis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rhenium Lipiodol
Arm Description
Hepatic Intra-Arterial Administration of radio-active lipiodol.
Outcomes
Primary Outcome Measures
Maximal tolerated dose
Toxicity CTC grade ≥ 3 with CTCAE version 4.
Secondary Outcome Measures
Bio-availability
Measurement by gamma-scintigraphy and by measurement of radio-activity in urinary, faecal and blood samples.
Full Information
NCT ID
NCT01126463
First Posted
May 18, 2010
Last Updated
July 26, 2021
Sponsor
Center Eugene Marquis
Collaborators
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01126463
Brief Title
188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
Acronym
LIP-RE-I
Official Title
Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 26, 2010 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
August 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis
Collaborators
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinomas
Keywords
Hepatocellular carcinomas, lipiodol, rhenium, Non operable Hepatocellular carcinomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rhenium Lipiodol
Arm Type
Experimental
Arm Description
Hepatic Intra-Arterial Administration of radio-active lipiodol.
Intervention Type
Drug
Intervention Name(s)
188Re-SSS Lipiodol
Intervention Description
Hepatic Intra-Arterial Administration of radio-active lipiodol.
Primary Outcome Measure Information:
Title
Maximal tolerated dose
Description
Toxicity CTC grade ≥ 3 with CTCAE version 4.
Time Frame
Injection each week during 4 weeks and at month 2
Secondary Outcome Measure Information:
Title
Bio-availability
Description
Measurement by gamma-scintigraphy and by measurement of radio-activity in urinary, faecal and blood samples.
Time Frame
1, 6, 24 et 48 hours after treatment injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne GARIN, MD, PhD
Organizational Affiliation
Centre Eugene Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
16531923
Citation
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.
Results Reference
background
Learn more about this trial
188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas
We'll reach out to this number within 24 hrs