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DEB-TACE vs cTACE in HCC After TIPS

RecruitingPhase 3Ages 18 Years - 75 YearsAllFirst Affiliated Hospital, Sun Yat-Sen University
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • DEB-TACE
  • cTACE
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Where

1 site
The First Affiiated Hospital of Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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