.a.
- Conditions
- patients with HCC in the setting of cirrhosisTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 21.0Level: LLTClassification code 10024662Term: Liver cell carcinoma non-resectableSystem Organ Class: 100000004864
- Registration Number
- EUCTR2016-004004-60-IT
- Lead Sponsor
- IRCCS ISTITUTO CLINICO HUMANITAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 48
• HCC patients with Child-Pugh class A – B7 cirrhosis
• Multidisciplinary determination of suitability for tumor ablation or chemoembolization
• Intent to achieve complete tumor eradication
• Signature of Informed Consent
• Use of oral contraceptives for fertile age female patients
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
• Advanced disease (Child score B8 or higher)
• Pre-procedure determination of low likelihood for tumor eradication
• Relevant comorbidities, particularly gastric bleeding and neoplastic disease other than HCC
• Ongoing anti-inflammatory therapy
• Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the effect of anti-inflammatory drugs on cytokine production following treatment of cirrhotic patients being treated for HCC.;Secondary Objective: n.a.;Primary end point(s): Serum levels of inflammatory cytokines – IL-6 and HGF at baseline and day 7 (pre-op and day 7 blood draws).;Timepoint(s) of evaluation of this end point: 7 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ¿ High-sensitive C-reactive protein serum level at baseline, day 1 and 7<br>- VEGF serum level at day 1 and 7<br>- PIVKA and Endocan serum levels at baseline and day 7 <br>¿ Visual analog pain scale at baseline, day 1, 3, and 7<br>¿ Correlation of outcomes with bio-markers from pre-procedure biopsy (when available) such as COX2, IL6, HIF1a, VEGFr, CD34, Endocan and quantitative evaluation of inflammatory cells (T/NK and macrophages).;Timepoint(s) of evaluation of this end point: 7 days