Actively Recruiting
Drug Eluting Beads Transarterial Chemoembolization Versus Conventional Transarterial Chemoembolization for Beyond-Milan-Criteria Hepatocellular Carcinoma After Transjugular Intrahepatic Portosystemic Shunt A Phase 3 Open Label Multicenter Randomized Controlled Trial
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-05-01
206
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with hepatocellular carcinoma (HCC) that exceeds the Milan criteria and have previously undergone a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The trial compares two treatments: Drug-Eluting Bead Transarterial Chemoembolization (DEB-TACE) and Conventional Transarterial Chemoembolization (cTACE). This Phase 3, open-label, randomized controlled study aims to evaluate which treatment improves overall survival and other outcomes in this specific group of patients, as current treatment options after TIPS are limited and unclear. Participants will be randomly assigned to receive either DEB-TACE or cTACE. DEB-TACE uses drug-loaded microspheres to deliver chemotherapy directly to tumor arteries, while cTACE uses chemotherapy with ethiodized oil followed by embolization with gelatin sponge particles if needed. Both procedures involve superselective catheterization of tumor-feeding arteries by experienced radiologists. Treatments may be repeated every 6-8 weeks based on imaging results and liver function, stopping if disease progresses or liver impairment persists. During the 24-month treatment and follow-up phase, participants will undergo regular imaging assessments and monitoring to evaluate tumor response, disease progression, and side effects. Researchers will measure overall survival as the primary outcome, along with progression-free survival, tumor response, adverse events, and quality of life. The study will last approximately 48 months in total, including recruitment and follow-up, aiming to provide strong evidence for the best treatment approach in this patient population.
CONDITIONS
Brief Title
DEB-TACE vs cTACE in HCC After TIPS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or clinically confirmed primary hepatocellular carcinoma beyond Milan criteria (single lesion >5 cm or ≥3 lesions with at least one ≥3 cm).
- At least one measurable intrahepatic lesion with tumor burden ≤50%, no distant metastasis.
- Underwent TIPS procedure for variceal bleeding or refractory ascites with confirmed patent TIPS and Doppler 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 × 10⁹/L, platelets ≥50 × 10⁹/L, hemoglobin ≥90 g/L, serum albumin ≥30 g/L, bilirubin ≤50 μmol/L, AST/ALT ≤5 × upper limit of normal, ALP ≤4 × upper limit of normal, INR ≤2.3, creatinine ≤1.5 × upper limit of normal.
- No prior antitumor therapy within 12 months before enrollment.
You will not qualify if you...
- Diffuse hepatic infiltration, unassessable lesions on imaging, or tumor burden >50%.
- Simultaneous portal vein branch or main portal vein tumor thrombus.
- Liver transplantation or antitumor therapy after TIPS placement.
- Contraindications to TACE such as portosystemic shunt, hepatofugal 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.
- Concurrent other malignancy or history of other malignancy within the past 5 years.
- Severe cardiac, renal, or other organ dysfunction.
- Active clinically severe infection above 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated treatments every 6 to 8 weeks until disease progression or discontinuation
Participants receive transarterial chemoembolization using either drug-eluting beads or conventional methods. Treatments are repeated every 6 to 8 weeks based on imaging results and liver function, continuing until disease progression or other medical reasons require stopping.
Visits every 6 to 8 weeks for treatment and assessment
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.
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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