Actively Recruiting
DEB-TACE vs cTACE in HCC After TIPS
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-05-01
206
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DEB-TACE vs cTACE in HCC After TIPS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary hepatocellular carcinoma beyond Milan criteria (single tumor >5 cm or multiple tumors with at least one >3 cm)
- At least one measurable liver tumor with tumor burden 50% or less and no distant metastasis
- Undergone TIPS procedure for variceal bleeding or refractory ascites with confirmed patent TIPS and blood flow velocity >60 cm/s at 1-month follow-up
- Child-Pugh class A or B liver function
- Estimated survival of at least 3 months
- Adequate organ function including neutrophils ≥1.5 x 10^9/L, platelets ≥50 x 10^9/L, hemoglobin ≥90 g/L, serum albumin ≥30 g/L, bilirubin ≤50 µmol/L, AST/ALT ≤5 times upper limit of normal, ALP ≤4 times upper limit of normal, INR ≤2.3, creatinine ≤1.5 times upper limit of normal
- No prior antitumor therapy within 12 months before enrollment
You will not qualify if you...
- Diffuse liver infiltration, lesions not assessable by imaging, or tumor burden over 50%
- Tumor thrombus in portal vein branches or main portal vein
- Previous liver transplantation or antitumor therapy after TIPS
- Contraindications to TACE such as portosystemic shunt, reversed blood flow, or significant atherosclerosis
- Presence of brain metastases
- Allergy to contrast agents
- Pregnancy, breastfeeding, or planning pregnancy within 2 years
- Co-infection with HIV or syphilis
- Other current malignancies or history of malignancy within past 5 years
- Severe heart, kidney, or other organ dysfunction
- Active severe infection greater than Grade 2
- Psychiatric or psychological conditions impairing informed consent
- Participation in other drug clinical trials within 12 months prior to enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiiated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Wenzhe Fan, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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