n.a.

Prospective study of anti-inflammatory therapy post interventional radiological treatment of HCC in the cirrhotic patient. - Rad-HCC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004004-60-IT

Enrollment

Registered

2021-01-07

Start date

2017-03-02

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with HCC in the setting of cirrhosis MedDRA version: 21.0 Level: LLT Classification code 10024662 Term: Liver cell carcinoma non-resectable System Organ Class: 100000004864

Interventions

Trade Name: ARCOXIA - 90 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE IN BLISTER AL/AL Product Name: Arcoxia Product Code: n.a. Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ETORICOXIB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary end point(s): ¿ High-sensitive C-reactive protein serum level at baseline, day 1 and 7 - VEGF serum level at day 1 and 7 - PIVKA and Endocan serum levels at baseline and day 7 ¿ Visual analog pain scale at baseline, day 1, 3, and 7 ¿ 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	—

Measure

Time frame

Secondary end point(s): ¿ High-sensitive C-reactive protein serum level at baseline, day 1 and 7 - VEGF serum level at day 1 and 7 - PIVKA and Endocan serum levels at baseline and day 7 ¿ Visual analog pain scale at baseline, day 1, 3, and 7 ¿ 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

—

Countries

Italy

Contacts

Public Contactn.a.

IRCCS Istituto Clinico Humanitas

francesco.minuti@humanitas.it0282244033

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026