OncoMatch/Clinical Trials/NCT07322848
DEB-TACE vs cTACE in HCC After TIPS
Is NCT07322848 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for hepatocellular carcinoma (hcc).
This is a Phase 3, open-label, multicenter, randomized controlled clinical trial designed to evaluate the efficacy and safety of Drug-Eluting Bead Transarterial Chemoembolization (DEB-TACE) compared with Conventional Transarterial Chemoembolization (cTACE) in patients with hepatocellular carcinoma (HCC) that is beyond the Milan criteria and who have previously undergone a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The TIPS procedure is commonly performed to manage complications of portal hypertension, such as variceal bleeding or refractory ascites, in patients with cirrhosis. However, after TIPS, treatment options for HCC-particularly in cases exceeding the Milan criteria-remain limited and not well-defined in current guidelines. While TACE is a standard locoregional therapy for intermediate-stage HCC, its application in patients with a prior TIPS is controversial due to altered hepatic hemodynamics, which may increase the risk of liver toxicity and compromise treatment safety and efficacy. Preliminary retrospective data suggest that DEB-TACE, which uses calibrated drug-eluting microspheres, may offer a safer and more effective alternative to cTACE in this specific patient population by providing more controlled drug delivery and potentially reducing systemic and hepatic toxicity. The primary objective of this study is to determine whether DEB-TACE improves Overall Survival (OS) compared to cTACE in patients with beyond-Milan HCC after TIPS. Secondary objectives include comparing the safety profile, Progression-Free Survival (PFS), Objective Response Rate (ORR), Disease Control Rate (DCR), and Quality of Life (QoL) between the two treatment arms. The study aims to enroll 206 participants who will be randomly assigned in a 1:1 ratio to receive either DEB-TACE or cTACE. The trial will include a 24-month recruitment period and a 24-month treatment and follow-up phase, with a total study duration of 48 months. By directly comparing these two TACE approaches in a prospectively defined and randomized setting, this study seeks to provide high-level evidence to guide the optimal locoregional treatment strategy for HCC patients with a history of TIPS placement.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Prior therapy
Must have received: TIPS procedure — secondary prevention of variceal bleeding or refractory ascites
underwent TIPS procedure for secondary prevention of variceal bleeding or refractory ascites
Cannot have received: antitumor therapy
Exception: no prior antitumor therapy within 12 months before enrollment
No prior antitumor therapy within 12 months before enrollment
Cannot have received: liver transplantation
underwent liver transplantation or antitumor therapy after TIPS placement
Lab requirements
Blood counts
Neutrophils ≥1.5 × 10⁹/L; Platelets ≥50 × 10⁹/L; Hemoglobin ≥90 g/L
Kidney function
Creatinine ≤1.5 × ULN
Liver function
Serum albumin ≥30 g/L; Bilirubin ≤50 μmol/L; AST/ALT ≤5 × ULN; ALP ≤4 × ULN; INR ≤2.3
Cardiac function
severe cardiac dysfunction [excluded]
adequate organ function: Neutrophils ≥1.5 × 10⁹/L; Platelets ≥50 × 10⁹/L; Hemoglobin ≥90 g/L; Serum albumin ≥30 g/L; Bilirubin ≤50 μmol/L; AST/ALT ≤5 × ULN, ALP ≤4 × ULN; INR ≤2.3; Creatinine ≤1.5 × ULN. severe cardiac, renal, or other organ dysfunction [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify