Comparing DEB-TACE and cTACE for liver cancer after TIPS

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

This trial will test whether DEB-TACE or conventional TACE works better and is safer for people with hepatocellular carcinoma beyond Milan criteria who previously had a TIPS.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07322848 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, open-label, randomized multicenter trial comparing drug-eluting bead transarterial chemoembolization (DEB-TACE) with conventional TACE (cTACE) in patients with hepatocellular carcinoma (HCC) exceeding Milan criteria who have undergone a transjugular intrahepatic portosystemic shunt (TIPS). Eligible participants must have a patent TIPS with adequate Doppler flow, Child-Pugh class A or B liver function, measurable intrahepatic disease with tumor burden ≤50%, and no recent antitumor therapy. The trial will monitor both efficacy outcomes (tumor response, local control) and safety endpoints related to liver function and procedure‑related complications given altered hepatic hemodynamics after TIPS. Treatment arms will follow standard DEB‑TACE or cTACE protocols with scheduled imaging and laboratory follow-up to compare benefits and risks.

Who should consider this trial

Good fit: Ideal candidates are adults with primary HCC beyond Milan criteria, a patent TIPS with documented flow, Child‑Pugh A or B, measurable intrahepatic tumor burden ≤50%, no distant metastasis, and adequate blood and organ function.

Not a fit: Patients with diffuse hepatic infiltration, unassessable lesions, tumor burden >50%, extrahepatic metastasis, or decompensated liver disease (e.g., Child‑Pugh C) are unlikely to benefit from the interventions tested here.

Why it matters

Potential benefit: If successful, the trial could identify a safer and more effective TACE approach for patients with HCC after TIPS, improving tumor control while reducing liver complications.

How similar studies have performed: Prior comparisons of DEB‑TACE and cTACE in general HCC populations have shown mixed efficacy but often lower systemic toxicity with DEB‑TACE, while specific data on outcomes after TIPS remain limited.

Eligibility criteria

Inclusion Criteria:

1. 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 intrahepatic measurable lesion with tumor burden ≤50%, no distant metastasis. No prior antitumor therapy within 12 months before enrollment.
2. underwent TIPS procedure for secondary prevention of variceal bleeding or refractory ascites. Confirmed patent TIPS at 1-month follow-up with portosystemic blood flow visible throughout the shunt and Doppler velocity \> 60 cm/s.
3. child-Pugh class A or B.
4. estimated survival ≥3 months.
5. 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 × upper limit of normal (ULN), ALP ≤4 × ULN; INR ≤2.3; Creatinine ≤1.5 × ULN.

Exclusion Criteria:

1. diffuse hepatic infiltration, unassessable lesions on imaging, or tumor burden \>50%.
2. simultaneous portal vein branch tumor thrombus or main portal vein tumor thrombus.
3. underwent liver transplantation or antitumor therapy after TIPS placement.
4. contraindications to TACE (e.g., portosystemic shunt, hepatofugal blood flow, significant atherosclerosis).
5. presence of brain metastases.
6. Allergy to contrast agents.
7. pregnancy, breastfeeding, or planning pregnancy within 2 years.
8. co-infection with HIV or syphilis.
9. concurrent other malignancy or history of other malignancy within the past 5 years.
10. severe cardiac, renal, or other organ dysfunction.
11. active clinically severe infection \> Grade 2 (per NCI-CTC v5.0).
12. psychiatric/psychological conditions that may impair informed consent.
13. participation in other drug clinical trials within 12 months prior to enrollment.

Where this trial is running

Guangzhou, Guangdong

• The First Affiiated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Wenzhe Fan, Dr.

Conditions Hepatocellular Carcinoma; TACE; TIPS; DEB-TACE; cTACE