TRANSARTERIAL EMBOLIZATION ALONE VERSUS DRUG-ELUTING BEADS CHEMOEMBOLIZATION FOR HEPATOCELLULAR CARCINOMA. A RANDOMIZED CONTROLLED TRIAL”

Phase 1

• Conditions: Hepatocellular carcinoma; MedDRA version: 21.0Level: LLTClassification code 10024662Term: Liver cell carcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000740-25-IT
• Lead Sponsor: AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

First-level eligibility criteria include:
1) diagnosis of HCC according to the AASLD criteria [26];
2) patients =18 years;
2) HCC unsuitable for curative treatment or for failure / recurrence after resection / ablation and diagnosed according to the AASLD criteria [26];
3) no previous treatment of target lesions (previous treatments include surgical resections on non-target lesions);
4) Child-Pugh Class A or B (maximum score 7);
5) ECOG Performance Status (PS) <2;
6) measurable target lesion according to mRECIST [24].
Second-level eligibility criteria include:
1) the prognostic score modified hepatoma arterial-embolization prognostic score (m-HAP-II) [27], based on bilirubin, albumin, alpha-fetoprotein, number of lesions and tumor size, which divides patients into 4 classes (A, B, C, D) with different survivals and is useful for stratifying the prognosis [28]. The first selection criteria will be the fulfillment of class B or C of m-HAP-II;
2) UNOS / TNM stage: patients with T1, T2, T3 and T4a will be included.
These two main criteria will be used for the stratification of patients before randomization in order to obtain an identical prevalence of the m-HAP-II B / C classes and of the UNO / TNM stages from T1 to T4a.
3) obtaining informed consent.
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 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1) HCC infiltrative;
2) neoplastic invasion of a portal branch and of the common portal trunk;
3) equivocal liver injury;
4) advanced liver disease (bilirubin levels> 2.5 mg dl-1, albumin <30 g l-1, platelets <50 x 109 / L, INR> 1.5);
5) ascites and / or esophageal varices F3;
6) other tumors in the previous 5 years;
7) technical contraindications to arteriography or TACE.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified