Hepatocellular carcinoma MedDRA version: 21.0 Level: LLT Classification code 10024662 Term: Liver cell carcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ADRIBLASTINA - 50 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONE POLVERE
Product Name: Doxorubicina
Product Code: [Doxorubicina]
Pharmaceutical Form: Powder and solvent for solution for in
Sponsors
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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 1.5); 5) ascites and / or esophageal varices F3; 6) other tumors in the previous 5 years; 7) technical contraindications to arteriography or TACE.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare TTP since randomization, as recommended from expert panel opinion [26] after TAE and DEB-TACE in a homogeneous HCC patients population and using small size beads in both arms.;Secondary Objective: Compare safety -Severe adverse events (SAE)-,radiologic tumor response (mRECIST) and OS in the two arms. To date, no evidence exists that TAE can ameliorate patient survival in regards to TACE but literature suggests a reduction in the SAE occurrence in patients submitted to TAE. Compare cost-effectiveness of TACE vs TAE after the entire follow-up, because, if oncologic outcomes for these two procedures are equivalent, cost containment alone should be a strong reason to support a shift from TACE to TAE. Experimental Design;Primary end point(s): The study was designed, in relation to the primary endpoint, as an equivalence trial between the two methods of intra-arterial HCC treatment, ie DEB-TACE and TAE. The TTP considered as the reference value for the patient arm submitted to DEB-TACE is 9 months, based on the results of our previous multicentric experience [6]. The TTP standard deviation is not expected to exceed 6 months, after careful patient selection. The limit of equivalence is set at no more than 5 months between the two arms. Then, using the appropriate formulas, each arm will be made up of 69 patients (alpha: 0.05; beta: 0.80). Taking into account a 10% drop-out, the final sample size for each arm will be 77 patients (154 total).;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Security. AEs and SAEs will be monitored and registered. Each AE will be assessed during and after each treatment and at all check-ups and classified according to the NCIs Common Terminology Criteria for AE (CTCAE) version 3.0. AEs occurring within 4 weeks of each intra-arterial procedure will be considered related to treatment. The incidence of SAEs in both treatment embers will be ascertained by hypothesizing a reduction in SAE of 25% after DEB-TACE and by 19% after TAE. This hypothesis would require 607 patients per arm to be confirmed. To evaluate this hypothesis, the O'Brien-Fleming stopping boundaries will be used by performing the concluded enrollment analysis of the 69 patients for each arm and with the follow-up completed. A nominal p value <0.001 (z score: 3.15) will be required to confirm the hypothesis. If the p value is higher than this threshold (even if <0.05) the null hypothesis will not be rejected. - Effectiveness. The response will be evaluated by CT or MRI as a local response (per lesion) and global response (per patient), applying mRECIST [24], 1 month after each TACE and thereafter every 3 months for at least 2 years. -Survival. Through proper patient selection, we expect a standard deviation of average survival of no more than 10 months. To draw this equivalence study we expect a difference in mean survival of not more than 5 months (equivalence limit) between the two treatment groups, DEB-TACE and TAE. Using the formulas proposed by Julious et al [25], each arm will be made up of 69 patients (alpha: 0.05; beta: 0.80). To obtain more reliable estimates and accounting for any drop-out from the study, 10% of patients will be added to the initial sample size, resulting in 77 patients for each arm. - Costs. Cost effectiveness will be assessed from a third-party perspective, thus including only direct costs of procedures and related costs (hospitalization, imaging, etc.). The effectiveness will be assessed by measuring lif | — |
Countries
Italy
Contacts
Public ContactU.O. Radiologia (Golfieri)
AOU di Bologna
Outcome results
None listed