Status:
UNKNOWN
Transarterial Embolization Alone Versus Drug-Eluting Beads Chemoembolization for Hepatocellular Carcinoma
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Developed in Japan in the 1980s, TACE became the most frequent treatment for unresectable hepatocellular carcinoma (HCC) in patients with preserved hepatic function after 2002, when two radiochemother...
Detailed Description
Specific Aims Specific aim 1 Compare time to progression (TTP) treated with TAE and DEB-TACE in a homogeneous hepatocellular carcinoma (HCC) patient population Specific aim 2 Compare * safety - sev...
Eligibility Criteria
Inclusion
- \- First level eligibility criteria include
- HCC diagnosis according to the AASLD criteria \[26\];
- patients ≥18 years;
- HCC unsuitable for curative treatment or had failed/recurred after resection/ablation diagnosed according to the AASLD criteria;
- no previous treatment in target lesions (prior treatments including resection on non-target lesions will be accepted);
- Child-Pugh class A or B (max score 7);
- ECOG Performance Status (PS) \<2;
- target lesion measurable according to mRECIST.
- Second level eligibility criteria include:
- The modified hepatoma arterial-embolization prognostic score (m-HAP-II), based on bilirubin, albumin, serum alpha fetoprotein, tumor number and tumor size, divides patients in 4 classes (A, B, C, D) with different survivals and is useful for prognosis stratification. The first selection criteria will be m-HAP-II classes B or C fulfilment.
- The UNOS/TNM stage: only patients with T1, T2, T3 and T4 tumors will be included.
- These two main criteria will be used for stratification of patients prior to randomization in order to obtain identical prevalence of m-HAP-II classes B/C and of UNOS/TNM stages from T1 to T4a
- obtaining of the informed consent.
Exclusion
- infiltrative HCC;
- neoplastic branch or main portal vein invasion;
- equivocal hepatic lesion;
- advanced liver disease (bilirubin levels \>2.5 mg dl-1, albumin \<30 g l-1, platelets \<50 x 109/L, INR \>1.5);
- ascites and/or F3 oesophageal varices;
- other tumors in the previous 5 years;
- technical contraindications to arteriography or TACE.
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04803019
Start Date
December 4 2019
End Date
April 30 2022
Last Update
March 19 2021
Active Locations (1)
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1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy