Intra-Arterial hepatic administration of SIR-Spheres for the advanced HEPATOCARCINOMA. CLINICAL TRIAL OF PHASE II - ND
- Conditions
- Hepatocarcinoma HCCMedDRA version: 6.1Level: PTClassification code 10019697
- Registration Number
- EUCTR2005-005183-82-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Diagnosis of HCC second the criteria of the Consensus Conference of Barcelona. The last executed diagnostic radiological surveying within 1 month from enlistment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1 Infiltrating HCC. 2 Equivocal, not measurable or not valued tumor hepatic.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to estimate the impact of the administration of Sir-Spheres in terms of tolerance and clinical answer;Secondary Objective: to estimate the survival and the quality of the life;Primary end point(s): tumoral answer with the criteria RECIST
- Secondary Outcome Measures
Name Time Method