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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

Comparing DEB-TACE and cTACE for liver cancer after TIPS

Official title: 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

Run by First Affiliated Hospital, Sun Yat-Sen University · NCT07322848 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment206 (estimated)
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedMay 1, 2026
Trial IDNCT07322848 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Hepatocellular Carcinoma (HCC) 119TACE 6TIPS 5First Affiliated Hospital, Sun Yat-Sen University 24
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.